{
"NDC": [
{
"NDCCode": "0832-1430-75",
"PackageDescription": "1 BOTTLE in 1 CARTON (0832-1430-75) / 7.5 mL in 1 BOTTLE",
"NDC11Code": "00832-1430-75",
"ProductNDC": "0832-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin And Dexamethasone",
"NonProprietaryName": "Ciprofloxacin Hydrochloride And Dexamethasone",
"DosageFormName": "SUSPENSION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20260106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216487",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE",
"StrengthNumber": "3; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260213",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin and dexamethasone, otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: 1 Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus,Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.( 1) , 2 Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureusand Pseudomonas aeruginosa. .",
"Description": "Ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension, USP contains the quinolone antimicrobial, ciprofloxacin hydrochloride, USP, combined with the corticosteroid, dexamethasone, USP, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin and dexamethasone, USP, otic suspension contains ciprofloxacin hydrochloride, USP (equivalent to 3 mg ciprofloxacin base) and 1 mg dexamethasone, USP. The inactive ingredients are acetic acid, boric acid, benzalkonium chloride (0.01%, as a preservative), edetate disodium, hydroxyethyl cellulose, purified water, sodium acetate, sodium chloride, and tyloxapol. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The empirical formula is C 17H 18FN 3O 3∙HCl∙H 2O. The molecular weight is 385.82 g/mol and the structural formula is:. Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is C 22H 29FO 5. The molecular weight is 392.46 g/mol and the structural formula is:. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "43744-832-75",
"PackageDescription": "15000 g in 1 DRUM (43744-832-75)",
"NDC11Code": "43744-0832-75",
"ProductNDC": "43744-832",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ronidazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120103",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "RONIDAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "43742-1430-1",
"PackageDescription": "960 mL in 1 BOTTLE, PLASTIC (43742-1430-1)",
"NDC11Code": "43742-1430-01",
"ProductNDC": "43742-1430",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Coxsackie A2, A7, B1, B3, B4",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20190213",
"EndMarketingDate": "20240314",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B3",
"StrengthNumber": "75; 75; 75; 75; 75",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04"
},
{
"NDCCode": "0832-0285-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0832-0285-00) ",
"NDC11Code": "00832-0285-00",
"ProductNDC": "0832-0285",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bexarotene",
"NonProprietaryName": "Bexarotene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209886",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "BEXAROTENE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2023-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180725",
"SamplePackage": "N",
"IndicationAndUsage": "Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.",
"Description": "Bexarotene capsules are a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, polyethylene glycol, polysorbate and povidone. The capsule shell contains gelatin, glycerin, sorbitol, titanium dioxide and water."
},
{
"NDCCode": "0832-0630-11",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0832-0630-11) ",
"NDC11Code": "00832-0630-11",
"ProductNDC": "0832-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074953",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170321",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule contains 25 mg, 50 mg or 75 mg of clomipramine hydrochloride USP. Inactive ingredients: magnesium stearate, pregelatinized starch, and silicone dioxide. The capsule shells contain: D&C Yellow 10, FD&C Blue 1, FD&C Blue 2, FD&C Red 40, ferrous iron oxide, gelatin, pharmaceutical glaze, propylene glycol and titanium dioxide. The 25 mg capsule shells also contain iron oxide red and iron oxide yellow. The 50 mg capsule shells also contain FD&C Blue 1. The 75 mg capsule shells also contain D&C Red 33 and D&C Yellow 10."
},
{
"NDCCode": "0832-0631-11",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0832-0631-11) ",
"NDC11Code": "00832-0631-11",
"ProductNDC": "0832-0631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074953",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170321",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule contains 25 mg, 50 mg or 75 mg of clomipramine hydrochloride USP. Inactive ingredients: magnesium stearate, pregelatinized starch, and silicone dioxide. The capsule shells contain: D&C Yellow 10, FD&C Blue 1, FD&C Blue 2, FD&C Red 40, ferrous iron oxide, gelatin, pharmaceutical glaze, propylene glycol and titanium dioxide. The 25 mg capsule shells also contain iron oxide red and iron oxide yellow. The 50 mg capsule shells also contain FD&C Blue 1. The 75 mg capsule shells also contain D&C Red 33 and D&C Yellow 10."
},
{
"NDCCode": "0832-0632-11",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0832-0632-11) ",
"NDC11Code": "00832-0632-11",
"ProductNDC": "0832-0632",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074953",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170321",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule contains 25 mg, 50 mg or 75 mg of clomipramine hydrochloride USP. Inactive ingredients: magnesium stearate, pregelatinized starch, and silicone dioxide. The capsule shells contain: D&C Yellow 10, FD&C Blue 1, FD&C Blue 2, FD&C Red 40, ferrous iron oxide, gelatin, pharmaceutical glaze, propylene glycol and titanium dioxide. The 25 mg capsule shells also contain iron oxide red and iron oxide yellow. The 50 mg capsule shells also contain FD&C Blue 1. The 75 mg capsule shells also contain D&C Red 33 and D&C Yellow 10."
},
{
"NDCCode": "0832-1223-11",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0832-1223-11) ",
"NDC11Code": "00832-1223-11",
"ProductNDC": "0832-1223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212654",
"LabelerName": "Upsher-smith Laboratories, LLC",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210929",
"SamplePackage": "N"
},
{
"NDCCode": "10370-832-05",
"PackageDescription": "500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-832-05) ",
"NDC11Code": "10370-0832-05",
"ProductNDC": "10370-832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170526",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "10370-832-09",
"PackageDescription": "90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-832-09) ",
"NDC11Code": "10370-0832-09",
"ProductNDC": "10370-832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170407",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "10370-832-11",
"PackageDescription": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-832-11) ",
"NDC11Code": "10370-0832-11",
"ProductNDC": "10370-832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170522",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "43744-832-33",
"PackageDescription": "75 g in 1 DRUM (43744-832-33)",
"NDC11Code": "43744-0832-33",
"ProductNDC": "43744-832",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ronidazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120103",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "RONIDAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "52817-832-60",
"PackageDescription": "1 TUBE in 1 CARTON (52817-832-60) / 60 g in 1 TUBE",
"NDC11Code": "52817-0832-60",
"ProductNDC": "52817-832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213636",
"LabelerName": "Trupharma, LLC",
"SubstanceName": "DAPSONE",
"StrengthNumber": "75",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241120",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Dapsone gel, 7.5%, contains dapsone USP, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone, USP has an empirical formula of C 12H 12N 2O 2S. It is a white or slightly yellow-white, crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is:. Each gram of dapsone gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water. The mechanism of action of dapsone gel in treating acne vulgaris is not known."
},
{
"NDCCode": "52817-832-90",
"PackageDescription": "1 TUBE in 1 CARTON (52817-832-90) / 90 g in 1 TUBE",
"NDC11Code": "52817-0832-90",
"ProductNDC": "52817-832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213636",
"LabelerName": "Trupharma, LLC",
"SubstanceName": "DAPSONE",
"StrengthNumber": "75",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241120",
"SamplePackage": "N",
"IndicationAndUsage": "Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Dapsone gel, 7.5%, contains dapsone USP, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone, USP has an empirical formula of C 12H 12N 2O 2S. It is a white or slightly yellow-white, crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is:. Each gram of dapsone gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water. The mechanism of action of dapsone gel in treating acne vulgaris is not known."
},
{
"NDCCode": "90010-832-02",
"PackageDescription": "48209 mL in 1 BOTTLE (90010-832-02) ",
"NDC11Code": "90010-0832-02",
"ProductNDC": "90010-832",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natezone Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200807",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangzhou Cluster Mapping Supply Chain Co., Ltd",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "90010-832-08",
"PackageDescription": "11038 mL in 1 BOTTLE, PUMP (90010-832-08) ",
"NDC11Code": "90010-0832-08",
"ProductNDC": "90010-832",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natezone Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200807",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangzhou Cluster Mapping Supply Chain Co., Ltd",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "90010-832-12",
"PackageDescription": "13552 mL in 1 BOTTLE, PUMP (90010-832-12) ",
"NDC11Code": "90010-0832-12",
"ProductNDC": "90010-832",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natezone Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200807",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangzhou Cluster Mapping Supply Chain Co., Ltd",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0085-1430-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0085-1430-01) > 5 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "00085-1430-01",
"ProductNDC": "0085-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-06-05"
},
{
"NDCCode": "0085-1430-02",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0085-1430-02) > 14 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "00085-1430-02",
"ProductNDC": "0085-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-06-05"
},
{
"NDCCode": "0085-1430-03",
"PackageDescription": "5 PACKET in 1 CARTON (0085-1430-03) / 1 CAPSULE in 1 PACKET (0085-1430-05) ",
"NDC11Code": "00085-1430-03",
"ProductNDC": "0085-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990811",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
},
{
"NDCCode": "0085-1430-04",
"PackageDescription": "14 PACKET in 1 CARTON (0085-1430-04) / 1 CAPSULE in 1 PACKET (0085-1430-05) ",
"NDC11Code": "00085-1430-04",
"ProductNDC": "0085-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990811",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
},
{
"NDCCode": "0220-1430-41",
"PackageDescription": "6 [hp_C] in 1 TUBE (0220-1430-41) ",
"NDC11Code": "00220-1430-41",
"ProductNDC": "0220-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clematis Erecta",
"NonProprietaryName": "Clematis Recta Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "CLEMATIS RECTA FLOWERING TOP",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/6[hp_C]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Rx Only*."
},
{
"NDCCode": "0280-1430-32",
"PackageDescription": "1600 POUCH in 1 CASE (0280-1430-32) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-1430-32",
"ProductNDC": "0280-1430",
"ProductTypeName": "HUMAN OTC DRUG",
"NonProprietaryName": "Aspirin, Doxylamine Succinate, Phenylephrine Bitartrate, And Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET, EFFERVESCENT",
"StartMarketingDate": "20100801",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "500; 10; 6.25; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-AUG-10"
},
{
"NDCCode": "0378-1430-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-05) ",
"NDC11Code": "00378-1430-05",
"ProductNDC": "0378-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960719",
"EndMarketingDate": "20300131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074642",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960719",
"EndMarketingDatePackage": "20300131",
"SamplePackage": "N"
},
{
"NDCCode": "0378-1430-77",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-77) ",
"NDC11Code": "00378-1430-77",
"ProductNDC": "0378-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nicardipine Hydrochloride",
"NonProprietaryName": "Nicardipine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960719",
"EndMarketingDate": "20300131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074642",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NICARDIPINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960719",
"EndMarketingDatePackage": "20300131",
"SamplePackage": "N"
},
{
"NDCCode": "0536-1430-97",
"PackageDescription": "1 BOTTLE in 1 CARTON (0536-1430-97) / 118 mL in 1 BOTTLE",
"NDC11Code": "00536-1430-97",
"ProductNDC": "0536-1430",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rugby Mucus And Chest Congestion 541",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes."
},
{
"NDCCode": "13838-1430-1",
"PackageDescription": "20 mL in 1 BOTTLE, GLASS (13838-1430-1) ",
"NDC11Code": "13838-1430-01",
"ProductNDC": "13838-1430",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Taraxacum (m)",
"NonProprietaryName": "Taraxacum Officinale",
"DosageFormName": "TINCTURE",
"RouteName": "ORAL",
"StartMarketingDate": "20051001",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Phytodyne Inc.",
"SubstanceName": "TARAXACUM OFFICINALE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20051001",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N"
},
{
"NDCCode": "22840-1430-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-1430-2) ",
"NDC11Code": "22840-1430-02",
"ProductNDC": "22840-1430",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Aspen Pollen",
"NonProprietaryName": "Populus Tremuloides",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "POPULUS TREMULOIDES POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "22840-1430-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-1430-4) ",
"NDC11Code": "22840-1430-04",
"ProductNDC": "22840-1430",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Aspen Pollen",
"NonProprietaryName": "Populus Tremuloides",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "POPULUS TREMULOIDES POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "36987-1430-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1430-1)",
"NDC11Code": "36987-1430-01",
"ProductNDC": "36987-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cauliflower",
"NonProprietaryName": "Cauliflower",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "CAULIFLOWER",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
}
]
}
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<NDC>
<NDCCode>0832-1430-75</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0832-1430-75) / 7.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00832-1430-75</NDC11Code>
<ProductNDC>0832-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin And Dexamethasone</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20260106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216487</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE</SubstanceName>
<StrengthNumber>3; 1</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin and dexamethasone, otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: 1 Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus,Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.( 1) , 2 Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureusand Pseudomonas aeruginosa. .</IndicationAndUsage>
<Description>Ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension, USP contains the quinolone antimicrobial, ciprofloxacin hydrochloride, USP, combined with the corticosteroid, dexamethasone, USP, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin and dexamethasone, USP, otic suspension contains ciprofloxacin hydrochloride, USP (equivalent to 3 mg ciprofloxacin base) and 1 mg dexamethasone, USP. The inactive ingredients are acetic acid, boric acid, benzalkonium chloride (0.01%, as a preservative), edetate disodium, hydroxyethyl cellulose, purified water, sodium acetate, sodium chloride, and tyloxapol. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The empirical formula is C 17H 18FN 3O 3∙HCl∙H 2O. The molecular weight is 385.82 g/mol and the structural formula is:. Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is C 22H 29FO 5. The molecular weight is 392.46 g/mol and the structural formula is:. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43744-832-75</NDCCode>
<PackageDescription>15000 g in 1 DRUM (43744-832-75)</PackageDescription>
<NDC11Code>43744-0832-75</NDC11Code>
<ProductNDC>43744-832</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ronidazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120103</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>RONIDAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43742-1430-1</NDCCode>
<PackageDescription>960 mL in 1 BOTTLE, PLASTIC (43742-1430-1)</PackageDescription>
<NDC11Code>43742-1430-01</NDC11Code>
<ProductNDC>43742-1430</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Coxsackie A2, A7, B1, B3, B4</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20190213</StartMarketingDate>
<EndMarketingDate>20240314</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B3</SubstanceName>
<StrengthNumber>75; 75; 75; 75; 75</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0832-0285-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0832-0285-00) </PackageDescription>
<NDC11Code>00832-0285-00</NDC11Code>
<ProductNDC>0832-0285</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bexarotene</ProprietaryName>
<NonProprietaryName>Bexarotene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209886</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>BEXAROTENE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.</IndicationAndUsage>
<Description>Bexarotene capsules are a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, polyethylene glycol, polysorbate and povidone. The capsule shell contains gelatin, glycerin, sorbitol, titanium dioxide and water.</Description>
</NDC>
<NDC>
<NDCCode>0832-0630-11</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0832-0630-11) </PackageDescription>
<NDC11Code>00832-0630-11</NDC11Code>
<ProductNDC>0832-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074953</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule contains 25 mg, 50 mg or 75 mg of clomipramine hydrochloride USP. Inactive ingredients: magnesium stearate, pregelatinized starch, and silicone dioxide. The capsule shells contain: D&C Yellow 10, FD&C Blue 1, FD&C Blue 2, FD&C Red 40, ferrous iron oxide, gelatin, pharmaceutical glaze, propylene glycol and titanium dioxide. The 25 mg capsule shells also contain iron oxide red and iron oxide yellow. The 50 mg capsule shells also contain FD&C Blue 1. The 75 mg capsule shells also contain D&C Red 33 and D&C Yellow 10.</Description>
</NDC>
<NDC>
<NDCCode>0832-0631-11</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0832-0631-11) </PackageDescription>
<NDC11Code>00832-0631-11</NDC11Code>
<ProductNDC>0832-0631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074953</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule contains 25 mg, 50 mg or 75 mg of clomipramine hydrochloride USP. Inactive ingredients: magnesium stearate, pregelatinized starch, and silicone dioxide. The capsule shells contain: D&C Yellow 10, FD&C Blue 1, FD&C Blue 2, FD&C Red 40, ferrous iron oxide, gelatin, pharmaceutical glaze, propylene glycol and titanium dioxide. The 25 mg capsule shells also contain iron oxide red and iron oxide yellow. The 50 mg capsule shells also contain FD&C Blue 1. The 75 mg capsule shells also contain D&C Red 33 and D&C Yellow 10.</Description>
</NDC>
<NDC>
<NDCCode>0832-0632-11</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0832-0632-11) </PackageDescription>
<NDC11Code>00832-0632-11</NDC11Code>
<ProductNDC>0832-0632</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074953</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride, USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule contains 25 mg, 50 mg or 75 mg of clomipramine hydrochloride USP. Inactive ingredients: magnesium stearate, pregelatinized starch, and silicone dioxide. The capsule shells contain: D&C Yellow 10, FD&C Blue 1, FD&C Blue 2, FD&C Red 40, ferrous iron oxide, gelatin, pharmaceutical glaze, propylene glycol and titanium dioxide. The 25 mg capsule shells also contain iron oxide red and iron oxide yellow. The 50 mg capsule shells also contain FD&C Blue 1. The 75 mg capsule shells also contain D&C Red 33 and D&C Yellow 10.</Description>
</NDC>
<NDC>
<NDCCode>0832-1223-11</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0832-1223-11) </PackageDescription>
<NDC11Code>00832-1223-11</NDC11Code>
<ProductNDC>0832-1223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212654</ApplicationNumber>
<LabelerName>Upsher-smith Laboratories, LLC</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10370-832-05</NDCCode>
<PackageDescription>500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-832-05) </PackageDescription>
<NDC11Code>10370-0832-05</NDC11Code>
<ProductNDC>10370-832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>10370-832-09</NDCCode>
<PackageDescription>90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-832-09) </PackageDescription>
<NDC11Code>10370-0832-09</NDC11Code>
<ProductNDC>10370-832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>10370-832-11</NDCCode>
<PackageDescription>30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-832-11) </PackageDescription>
<NDC11Code>10370-0832-11</NDC11Code>
<ProductNDC>10370-832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>43744-832-33</NDCCode>
<PackageDescription>75 g in 1 DRUM (43744-832-33)</PackageDescription>
<NDC11Code>43744-0832-33</NDC11Code>
<ProductNDC>43744-832</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ronidazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120103</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>RONIDAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52817-832-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52817-832-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>52817-0832-60</NDC11Code>
<ProductNDC>52817-832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213636</ApplicationNumber>
<LabelerName>Trupharma, LLC</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Dapsone gel, 7.5%, contains dapsone USP, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone, USP has an empirical formula of C 12H 12N 2O 2S. It is a white or slightly yellow-white, crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is:. Each gram of dapsone gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water. The mechanism of action of dapsone gel in treating acne vulgaris is not known.</Description>
</NDC>
<NDC>
<NDCCode>52817-832-90</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52817-832-90) / 90 g in 1 TUBE</PackageDescription>
<NDC11Code>52817-0832-90</NDC11Code>
<ProductNDC>52817-832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213636</ApplicationNumber>
<LabelerName>Trupharma, LLC</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Dapsone gel, 7.5%, contains dapsone USP, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone, USP has an empirical formula of C 12H 12N 2O 2S. It is a white or slightly yellow-white, crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is:. Each gram of dapsone gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water. The mechanism of action of dapsone gel in treating acne vulgaris is not known.</Description>
</NDC>
<NDC>
<NDCCode>90010-832-02</NDCCode>
<PackageDescription>48209 mL in 1 BOTTLE (90010-832-02) </PackageDescription>
<NDC11Code>90010-0832-02</NDC11Code>
<ProductNDC>90010-832</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natezone Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangzhou Cluster Mapping Supply Chain Co., Ltd</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>90010-832-08</NDCCode>
<PackageDescription>11038 mL in 1 BOTTLE, PUMP (90010-832-08) </PackageDescription>
<NDC11Code>90010-0832-08</NDC11Code>
<ProductNDC>90010-832</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natezone Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangzhou Cluster Mapping Supply Chain Co., Ltd</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>90010-832-12</NDCCode>
<PackageDescription>13552 mL in 1 BOTTLE, PUMP (90010-832-12) </PackageDescription>
<NDC11Code>90010-0832-12</NDC11Code>
<ProductNDC>90010-832</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natezone Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangzhou Cluster Mapping Supply Chain Co., Ltd</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0085-1430-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0085-1430-01) > 5 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00085-1430-01</NDC11Code>
<ProductNDC>0085-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-06-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0085-1430-02</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0085-1430-02) > 14 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00085-1430-02</NDC11Code>
<ProductNDC>0085-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-06-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0085-1430-03</NDCCode>
<PackageDescription>5 PACKET in 1 CARTON (0085-1430-03) / 1 CAPSULE in 1 PACKET (0085-1430-05) </PackageDescription>
<NDC11Code>00085-1430-03</NDC11Code>
<ProductNDC>0085-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>0085-1430-04</NDCCode>
<PackageDescription>14 PACKET in 1 CARTON (0085-1430-04) / 1 CAPSULE in 1 PACKET (0085-1430-05) </PackageDescription>
<NDC11Code>00085-1430-04</NDC11Code>
<ProductNDC>0085-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>0220-1430-41</NDCCode>
<PackageDescription>6 [hp_C] in 1 TUBE (0220-1430-41) </PackageDescription>
<NDC11Code>00220-1430-41</NDC11Code>
<ProductNDC>0220-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clematis Erecta</ProprietaryName>
<NonProprietaryName>Clematis Recta Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>CLEMATIS RECTA FLOWERING TOP</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/6[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rx Only*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-1430-32</NDCCode>
<PackageDescription>1600 POUCH in 1 CASE (0280-1430-32) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-1430-32</NDC11Code>
<ProductNDC>0280-1430</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<NonProprietaryName>Aspirin, Doxylamine Succinate, Phenylephrine Bitartrate, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<StartMarketingDate>20100801</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>500; 10; 6.25; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-AUG-10</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0378-1430-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-05) </PackageDescription>
<NDC11Code>00378-1430-05</NDC11Code>
<ProductNDC>0378-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960719</StartMarketingDate>
<EndMarketingDate>20300131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074642</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960719</StartMarketingDatePackage>
<EndMarketingDatePackage>20300131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-1430-77</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (0378-1430-77) </PackageDescription>
<NDC11Code>00378-1430-77</NDC11Code>
<ProductNDC>0378-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nicardipine Hydrochloride</ProprietaryName>
<NonProprietaryName>Nicardipine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960719</StartMarketingDate>
<EndMarketingDate>20300131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074642</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NICARDIPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960719</StartMarketingDatePackage>
<EndMarketingDatePackage>20300131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0536-1430-97</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0536-1430-97) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00536-1430-97</NDC11Code>
<ProductNDC>0536-1430</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rugby Mucus And Chest Congestion 541</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13838-1430-1</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, GLASS (13838-1430-1) </PackageDescription>
<NDC11Code>13838-1430-01</NDC11Code>
<ProductNDC>13838-1430</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Taraxacum (m)</ProprietaryName>
<NonProprietaryName>Taraxacum Officinale</NonProprietaryName>
<DosageFormName>TINCTURE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051001</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Phytodyne Inc.</LabelerName>
<SubstanceName>TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20051001</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>22840-1430-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1430-2) </PackageDescription>
<NDC11Code>22840-1430-02</NDC11Code>
<ProductNDC>22840-1430</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Aspen Pollen</ProprietaryName>
<NonProprietaryName>Populus Tremuloides</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>POPULUS TREMULOIDES POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-1430-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-1430-4) </PackageDescription>
<NDC11Code>22840-1430-04</NDC11Code>
<ProductNDC>22840-1430</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Aspen Pollen</ProprietaryName>
<NonProprietaryName>Populus Tremuloides</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>POPULUS TREMULOIDES POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>36987-1430-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1430-1)</PackageDescription>
<NDC11Code>36987-1430-01</NDC11Code>
<ProductNDC>36987-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cauliflower</ProprietaryName>
<NonProprietaryName>Cauliflower</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>CAULIFLOWER</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
</NDCList>