{
"NDC": [
{
"NDCCode": "67877-251-15",
"PackageDescription": "15 g in 1 TUBE (67877-251-15) ",
"NDC11Code": "67877-0251-15",
"ProductNDC": "67877-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088042",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120401",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is. Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate."
},
{
"NDCCode": "43353-251-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (43353-251-15) ",
"NDC11Code": "43353-0251-15",
"ProductNDC": "43353-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077955",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170216",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) , 2 Coronary Artery Disease (1.2) Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "43419-251-31",
"PackageDescription": "1 CONTAINER in 1 CARTON (43419-251-31) / 15 g in 1 CONTAINER",
"NDC11Code": "43419-0251-31",
"ProductNDC": "43419-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hera Black Cushion Foundation 26w1",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Amorepacific Corporation",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".9743; .249; .294",
"StrengthUnit": "g/15g; g/15g; g/15g",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "49999-251-15",
"PackageDescription": "15 g in 1 TUBE (49999-251-15)",
"NDC11Code": "49999-0251-15",
"ProductNDC": "49999-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065315",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50458-251-15",
"PackageDescription": "6 DIALPACK in 1 CARTON (50458-251-15) > 1 KIT in 1 DIALPACK (50458-251-00) ",
"NDC11Code": "50458-0251-15",
"ProductNDC": "50458-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ortho Tri Cyclen Lo",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20020822",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021241",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20020822",
"SamplePackage": "N"
},
{
"NDCCode": "59779-251-01",
"PackageDescription": "15 mL in 1 BOTTLE, PUMP (59779-251-01)",
"NDC11Code": "59779-0251-01",
"ProductNDC": "59779-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-aging Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110318",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "CVS PHARMACY",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "TO HELP REDUCE BACTERIA ON THE SKIN."
},
{
"NDCCode": "61387-251-02",
"PackageDescription": "15 g in 1 TUBE (61387-251-02) ",
"NDC11Code": "61387-0251-02",
"ProductNDC": "61387-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crash Cream",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230728",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Claridei Laboratories",
"SubstanceName": "WHITE PETROLATUM",
"StrengthNumber": "50",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230728",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if: 1 condition worsens, 2 symptoms last more than 7 days or clear up and occur again within a few days."
},
{
"NDCCode": "63187-251-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (63187-251-15) ",
"NDC11Code": "63187-0251-15",
"ProductNDC": "63187-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040268",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide."
},
{
"NDCCode": "67544-251-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-15) ",
"NDC11Code": "67544-0251-15",
"ProductNDC": "67544-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19890503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071611",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20080505",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. C20H21NHCl M.W. 311.9. Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "68577-251-01",
"PackageDescription": "1 TUBE in 1 CARTON (68577-251-01) / 15 mL in 1 TUBE",
"NDC11Code": "68577-0251-01",
"ProductNDC": "68577-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tir Tir Sun Bouncy Glow Lip Balm Spf 30 Burnt Maple",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260306",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COSMAX USA",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "13.5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260306",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Helps prevent sunburn."
},
{
"NDCCode": "71919-251-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-251-07) ",
"NDC11Code": "71919-0251-07",
"ProductNDC": "71919-251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Damiana",
"NonProprietaryName": "Turnera Diffusa Leafy Twig",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TURNERA DIFFUSA LEAFY TWIG",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "67877-229-15",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (67877-229-15) > 15 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "67877-0229-15",
"ProductNDC": "67877-229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20110309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077259",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110309",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4, and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol Maleate is stable at room temperature. Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of Timolol maleate in two dosage strengths: Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of Timolol Maleate). The pH of the solution is approximately 7.0, and the osmolarity is 274-328 mOsm. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative."
},
{
"NDCCode": "67877-257-90",
"PackageDescription": "6 BOTTLE in 1 CARTON (67877-257-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (67877-257-15) ",
"NDC11Code": "67877-0257-90",
"ProductNDC": "67877-257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lanthanum Carbonate",
"NonProprietaryName": "Lanthanum Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202329",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "LANTHANUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250510",
"SamplePackage": "N",
"IndicationAndUsage": "Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.",
"Description": "Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is."
},
{
"NDCCode": "67877-317-15",
"PackageDescription": "15 g in 1 TUBE (67877-317-15) ",
"NDC11Code": "67877-0317-15",
"ProductNDC": "67877-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088042",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120401",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is. Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate."
},
{
"NDCCode": "67877-318-15",
"PackageDescription": "15 g in 1 TUBE (67877-318-15) ",
"NDC11Code": "67877-0318-15",
"ProductNDC": "67877-318",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088042",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120401",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is. Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate."
},
{
"NDCCode": "67877-470-75",
"PackageDescription": "15 CREAM in 1 TUBE (67877-470-75) ",
"NDC11Code": "67877-0470-75",
"ProductNDC": "67877-470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207651",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TRIAMCINOLONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171228",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4 -diene-3,20 -dione,9 -fluoro -11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16 α)-], with the empirical formula C24H31FO6 and molecular weight 434.50 .CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol,Isopropyl Palmitate,Noncrystallizing sorbitol solution,Emulsifying Wax,Lactic Acid,Benzyl Alcohol andPurified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "67877-471-75",
"PackageDescription": "15 CREAM in 1 TUBE (67877-471-75) ",
"NDC11Code": "67877-0471-75",
"ProductNDC": "67877-471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207651",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TRIAMCINOLONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171228",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4 -diene-3,20 -dione,9 -fluoro -11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16 α)-], with the empirical formula C24H31FO6 and molecular weight 434.50 .CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol,Isopropyl Palmitate,Noncrystallizing sorbitol solution,Emulsifying Wax,Lactic Acid,Benzyl Alcohol andPurified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "67877-472-75",
"PackageDescription": "15 CREAM in 1 TUBE (67877-472-75) ",
"NDC11Code": "67877-0472-75",
"ProductNDC": "67877-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207651",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TRIAMCINOLONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171228",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4 -diene-3,20 -dione,9 -fluoro -11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16 α)-], with the empirical formula C24H31FO6 and molecular weight 434.50 .CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol,Isopropyl Palmitate,Noncrystallizing sorbitol solution,Emulsifying Wax,Lactic Acid,Benzyl Alcohol andPurified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "67877-610-15",
"PackageDescription": "150 CAPSULE in 1 BOTTLE (67877-610-15) ",
"NDC11Code": "67877-0610-15",
"ProductNDC": "67877-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidne Hydrochloride",
"NonProprietaryName": "Tizanidne Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212196",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine capsules are indicated for the treatment of spasticity in adults.",
"Description": "Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "67877-611-15",
"PackageDescription": "150 CAPSULE in 1 BOTTLE (67877-611-15) ",
"NDC11Code": "67877-0611-15",
"ProductNDC": "67877-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidne Hydrochloride",
"NonProprietaryName": "Tizanidne Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212196",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine capsules are indicated for the treatment of spasticity in adults.",
"Description": "Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "67877-612-15",
"PackageDescription": "150 CAPSULE in 1 BOTTLE (67877-612-15) ",
"NDC11Code": "67877-0612-15",
"ProductNDC": "67877-612",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidne Hydrochloride",
"NonProprietaryName": "Tizanidne Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212196",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine capsules are indicated for the treatment of spasticity in adults.",
"Description": "Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "67877-613-15",
"PackageDescription": "150 TABLET in 1 BOTTLE (67877-613-15) ",
"NDC11Code": "67877-0613-15",
"ProductNDC": "67877-613",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211798",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190127",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].",
"Description": "Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine hydrochloride is almost white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2- imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C9H8ClN5S-HCl, its molecular weight is 290.2 and its structural formula is:Tizanidine tablets, USP are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets, USP contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base) and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "67877-614-15",
"PackageDescription": "150 TABLET in 1 BOTTLE (67877-614-15) ",
"NDC11Code": "67877-0614-15",
"ProductNDC": "67877-614",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211798",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190127",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].",
"Description": "Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine hydrochloride is almost white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2- imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C9H8ClN5S-HCl, its molecular weight is 290.2 and its structural formula is:Tizanidine tablets, USP are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets, USP contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base) and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "67877-623-19",
"PackageDescription": "15 mL in 1 BOTTLE, PLASTIC (67877-623-19) ",
"NDC11Code": "67877-0623-19",
"ProductNDC": "67877-623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211748",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190209",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:.",
"Description": "Oxycodone hydrochloride oral solution, USP is an opioid agonist, available as solution in 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6one hydrochloride and has the following structural formula. C18H21NO4HCl MW 351.82 Oxycodone hydrochloride is a white to off-white powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 10 mL) and slightly soluble in ethanol and almost insoluble in ether or chloroform. Oxycodone hydrochloride oral solution, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: citric acid anhydrous , FD & C Red #40, glycerin, noncrystallizing sorbitol solution, poloxamer, purified water, sodium benzoate. Artificial raspberry flavor contains artificial flavors, citric acid, gum arabic, sodium benzoate."
},
{
"NDCCode": "67877-625-19",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (67877-625-19) > 15 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "67877-0625-19",
"ProductNDC": "67877-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211749",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190206",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)], reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated, , 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride oral solution USP is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4 .HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in oxycodone hydrochloride oral solution USP 100 mg per 5 mL (20 mg/ mL): include: anhydrous citric acid, sodium benzoate, saccharin sodium, sodium citrate dihydrate, noncrystallizing sorbitol solution, D & C yellow # 10, purified water. Artificial berry flavor contains artificial flavors, propylene glycol."
},
{
"NDCCode": "67877-751-58",
"PackageDescription": "1 KIT in 1 CARTON (67877-751-58) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE",
"NDC11Code": "67877-0751-58",
"ProductNDC": "67877-751",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214913",
"LabelerName": "Ascend Laboratories, LLC",
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for oral solution and other antibacterial drugs, vancomycin hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin hydrochloride for oral solution, USP for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl . The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution, USP kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre-measured Grape-Flavored Diluent, in the strengths and volumes listed in Table 3. Table 3: Vancomycin Strength, Diluent Volume and Vancomycin Concentration after Reconstitution. The Grape-Flavored Diluent used to reconstitute the oral solution contains: citric Acid (anhydrous), D&C Yellow 10, FD & C Red No 40, Grape Flavor 501417C, Methyl Paraben, Propylene Glycol, Propyl Paraben, Purified Water, Sucralose."
},
{
"NDCCode": "67877-751-81",
"PackageDescription": "1 KIT in 1 CARTON (67877-751-81) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE",
"NDC11Code": "67877-0751-81",
"ProductNDC": "67877-751",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214913",
"LabelerName": "Ascend Laboratories, LLC",
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for oral solution and other antibacterial drugs, vancomycin hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Vancomycin hydrochloride for oral solution, USP for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl . The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution, USP kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre-measured Grape-Flavored Diluent, in the strengths and volumes listed in Table 3. Table 3: Vancomycin Strength, Diluent Volume and Vancomycin Concentration after Reconstitution. The Grape-Flavored Diluent used to reconstitute the oral solution contains: citric Acid (anhydrous), D&C Yellow 10, FD & C Red No 40, Grape Flavor 501417C, Methyl Paraben, Propylene Glycol, Propyl Paraben, Purified Water, Sucralose."
},
{
"NDCCode": "59088-336-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-336-00) * 1 TUBE in 1 KIT > 118 mL in 1 TUBE (59088-333-08) * 1 BOX in 1 KIT > 1 in 1 BOX (30707387763634) * 1 TUBE in 1 KIT > 80 g in 1 TUBE (67877-251-80)",
"NDC11Code": "59088-0336-00",
"ProductNDC": "59088-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Silapak",
"NonProprietaryName": "Triamcinolone Acetonide Cream, Dimethicone Cream",
"DosageFormName": "KIT",
"StartMarketingDate": "20150623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088042",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2018-09-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-363-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-363-00) * 80 g in 1 TUBE (67877-251-80) * 1 in 1 PACKAGE (731477861930)",
"NDC11Code": "59088-0363-00",
"ProductNDC": "59088-363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Silazone Pak",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "KIT",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088042",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2018-08-16",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-367-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-367-00) * 1 TUBE in 1 KIT > 80 g in 1 TUBE (67877-251-80) * 1 TUBE in 1 KIT > 118 mL in 1 TUBE (59088-333-08)",
"NDC11Code": "59088-0367-00",
"ProductNDC": "59088-367",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Silapak",
"NonProprietaryName": "Triamcinolone Acetonide Cream Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20150818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088042",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2018-08-17",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>67877-251-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (67877-251-15) </PackageDescription>
<NDC11Code>67877-0251-15</NDC11Code>
<ProductNDC>67877-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088042</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is. Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.</Description>
</NDC>
<NDC>
<NDCCode>43353-251-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (43353-251-15) </PackageDescription>
<NDC11Code>43353-0251-15</NDC11Code>
<ProductNDC>43353-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077955</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) , 2 Coronary Artery Disease (1.2) Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>43419-251-31</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (43419-251-31) / 15 g in 1 CONTAINER</PackageDescription>
<NDC11Code>43419-0251-31</NDC11Code>
<ProductNDC>43419-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hera Black Cushion Foundation 26w1</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Amorepacific Corporation</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.9743; .249; .294</StrengthNumber>
<StrengthUnit>g/15g; g/15g; g/15g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49999-251-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (49999-251-15)</PackageDescription>
<NDC11Code>49999-0251-15</NDC11Code>
<ProductNDC>49999-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065315</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50458-251-15</NDCCode>
<PackageDescription>6 DIALPACK in 1 CARTON (50458-251-15) > 1 KIT in 1 DIALPACK (50458-251-00) </PackageDescription>
<NDC11Code>50458-0251-15</NDC11Code>
<ProductNDC>50458-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ortho Tri Cyclen Lo</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20020822</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021241</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59779-251-01</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, PUMP (59779-251-01)</PackageDescription>
<NDC11Code>59779-0251-01</NDC11Code>
<ProductNDC>59779-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-aging Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110318</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>CVS PHARMACY</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>TO HELP REDUCE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61387-251-02</NDCCode>
<PackageDescription>15 g in 1 TUBE (61387-251-02) </PackageDescription>
<NDC11Code>61387-0251-02</NDC11Code>
<ProductNDC>61387-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crash Cream</ProprietaryName>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Claridei Laboratories</LabelerName>
<SubstanceName>WHITE PETROLATUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if: 1 condition worsens, 2 symptoms last more than 7 days or clear up and occur again within a few days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-251-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (63187-251-15) </PackageDescription>
<NDC11Code>63187-0251-15</NDC11Code>
<ProductNDC>63187-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040268</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67544-251-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-15) </PackageDescription>
<NDC11Code>67544-0251-15</NDC11Code>
<ProductNDC>67544-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19890503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071611</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. C20H21NHCl M.W. 311.9. Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68577-251-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68577-251-01) / 15 mL in 1 TUBE</PackageDescription>
<NDC11Code>68577-0251-01</NDC11Code>
<ProductNDC>68577-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tir Tir Sun Bouncy Glow Lip Balm Spf 30 Burnt Maple</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COSMAX USA</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>13.5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-251-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-251-07) </PackageDescription>
<NDC11Code>71919-0251-07</NDC11Code>
<ProductNDC>71919-251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Damiana</ProprietaryName>
<NonProprietaryName>Turnera Diffusa Leafy Twig</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TURNERA DIFFUSA LEAFY TWIG</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67877-229-15</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (67877-229-15) > 15 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>67877-0229-15</NDC11Code>
<ProductNDC>67877-229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20110309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077259</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol maleate ophthalmic solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of Timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4, and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol Maleate is stable at room temperature. Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of Timolol maleate in two dosage strengths: Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of Timolol Maleate). The pH of the solution is approximately 7.0, and the osmolarity is 274-328 mOsm. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium chloride, sodium hydroxide to adjust pH, and water for injection. Benzalkonium chloride 0.01% is added as preservative.</Description>
</NDC>
<NDC>
<NDCCode>67877-257-90</NDCCode>
<PackageDescription>6 BOTTLE in 1 CARTON (67877-257-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (67877-257-15) </PackageDescription>
<NDC11Code>67877-0257-90</NDC11Code>
<ProductNDC>67877-257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lanthanum Carbonate</ProprietaryName>
<NonProprietaryName>Lanthanum Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202329</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>LANTHANUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.</IndicationAndUsage>
<Description>Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La2(CO3)3 xH2O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is.</Description>
</NDC>
<NDC>
<NDCCode>67877-317-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (67877-317-15) </PackageDescription>
<NDC11Code>67877-0317-15</NDC11Code>
<ProductNDC>67877-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088042</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is. Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.</Description>
</NDC>
<NDC>
<NDCCode>67877-318-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (67877-318-15) </PackageDescription>
<NDC11Code>67877-0318-15</NDC11Code>
<ProductNDC>67877-318</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088042</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is. Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.</Description>
</NDC>
<NDC>
<NDCCode>67877-470-75</NDCCode>
<PackageDescription>15 CREAM in 1 TUBE (67877-470-75) </PackageDescription>
<NDC11Code>67877-0470-75</NDC11Code>
<ProductNDC>67877-470</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207651</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4 -diene-3,20 -dione,9 -fluoro -11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16 α)-], with the empirical formula C24H31FO6 and molecular weight 434.50 .CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol,Isopropyl Palmitate,Noncrystallizing sorbitol solution,Emulsifying Wax,Lactic Acid,Benzyl Alcohol andPurified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>67877-471-75</NDCCode>
<PackageDescription>15 CREAM in 1 TUBE (67877-471-75) </PackageDescription>
<NDC11Code>67877-0471-75</NDC11Code>
<ProductNDC>67877-471</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207651</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4 -diene-3,20 -dione,9 -fluoro -11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16 α)-], with the empirical formula C24H31FO6 and molecular weight 434.50 .CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol,Isopropyl Palmitate,Noncrystallizing sorbitol solution,Emulsifying Wax,Lactic Acid,Benzyl Alcohol andPurified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>67877-472-75</NDCCode>
<PackageDescription>15 CREAM in 1 TUBE (67877-472-75) </PackageDescription>
<NDC11Code>67877-0472-75</NDC11Code>
<ProductNDC>67877-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207651</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4 -diene-3,20 -dione,9 -fluoro -11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16 α)-], with the empirical formula C24H31FO6 and molecular weight 434.50 .CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol,Isopropyl Palmitate,Noncrystallizing sorbitol solution,Emulsifying Wax,Lactic Acid,Benzyl Alcohol andPurified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate, Noncrystallizing sorbitol solution, Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>67877-610-15</NDCCode>
<PackageDescription>150 CAPSULE in 1 BOTTLE (67877-610-15) </PackageDescription>
<NDC11Code>67877-0610-15</NDC11Code>
<ProductNDC>67877-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidne Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidne Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212196</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine capsules are indicated for the treatment of spasticity in adults.</IndicationAndUsage>
<Description>Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67877-611-15</NDCCode>
<PackageDescription>150 CAPSULE in 1 BOTTLE (67877-611-15) </PackageDescription>
<NDC11Code>67877-0611-15</NDC11Code>
<ProductNDC>67877-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidne Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidne Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212196</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine capsules are indicated for the treatment of spasticity in adults.</IndicationAndUsage>
<Description>Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67877-612-15</NDCCode>
<PackageDescription>150 CAPSULE in 1 BOTTLE (67877-612-15) </PackageDescription>
<NDC11Code>67877-0612-15</NDC11Code>
<ProductNDC>67877-612</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidne Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidne Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212196</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine capsules are indicated for the treatment of spasticity in adults.</IndicationAndUsage>
<Description>Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67877-613-15</NDCCode>
<PackageDescription>150 TABLET in 1 BOTTLE (67877-613-15) </PackageDescription>
<NDC11Code>67877-0613-15</NDC11Code>
<ProductNDC>67877-613</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211798</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].</IndicationAndUsage>
<Description>Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine hydrochloride is almost white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2- imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C9H8ClN5S-HCl, its molecular weight is 290.2 and its structural formula is:Tizanidine tablets, USP are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets, USP contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base) and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>67877-614-15</NDCCode>
<PackageDescription>150 TABLET in 1 BOTTLE (67877-614-15) </PackageDescription>
<NDC11Code>67877-0614-15</NDC11Code>
<ProductNDC>67877-614</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211798</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].</IndicationAndUsage>
<Description>Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine hydrochloride is almost white to slightly yellow crystalline powder. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2- imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C9H8ClN5S-HCl, its molecular weight is 290.2 and its structural formula is:Tizanidine tablets, USP are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets, USP contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base) and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>67877-623-19</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, PLASTIC (67877-623-19) </PackageDescription>
<NDC11Code>67877-0623-19</NDC11Code>
<ProductNDC>67877-623</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211748</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:.</IndicationAndUsage>
<Description>Oxycodone hydrochloride oral solution, USP is an opioid agonist, available as solution in 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6one hydrochloride and has the following structural formula. C18H21NO4HCl MW 351.82 Oxycodone hydrochloride is a white to off-white powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 10 mL) and slightly soluble in ethanol and almost insoluble in ether or chloroform. Oxycodone hydrochloride oral solution, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: citric acid anhydrous , FD & C Red #40, glycerin, noncrystallizing sorbitol solution, poloxamer, purified water, sodium benzoate. Artificial raspberry flavor contains artificial flavors, citric acid, gum arabic, sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>67877-625-19</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (67877-625-19) > 15 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>67877-0625-19</NDC11Code>
<ProductNDC>67877-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone</ProprietaryName>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211749</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)], reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated, or are not expected to be tolerated, , 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride oral solution USP is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4 .HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in oxycodone hydrochloride oral solution USP 100 mg per 5 mL (20 mg/ mL): include: anhydrous citric acid, sodium benzoate, saccharin sodium, sodium citrate dihydrate, noncrystallizing sorbitol solution, D & C yellow # 10, purified water. Artificial berry flavor contains artificial flavors, propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>67877-751-58</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (67877-751-58) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE</PackageDescription>
<NDC11Code>67877-0751-58</NDC11Code>
<ProductNDC>67877-751</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214913</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for oral solution and other antibacterial drugs, vancomycin hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for oral solution, USP for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl . The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution, USP kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre-measured Grape-Flavored Diluent, in the strengths and volumes listed in Table 3. Table 3: Vancomycin Strength, Diluent Volume and Vancomycin Concentration after Reconstitution. The Grape-Flavored Diluent used to reconstitute the oral solution contains: citric Acid (anhydrous), D&C Yellow 10, FD & C Red No 40, Grape Flavor 501417C, Methyl Paraben, Propylene Glycol, Propyl Paraben, Purified Water, Sucralose.</Description>
</NDC>
<NDC>
<NDCCode>67877-751-81</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (67877-751-81) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE</PackageDescription>
<NDC11Code>67877-0751-81</NDC11Code>
<ProductNDC>67877-751</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214913</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for oral solution and other antibacterial drugs, vancomycin hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for oral solution, USP for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl . The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each vancomycin hydrochloride for oral solution, USP kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre-measured Grape-Flavored Diluent, in the strengths and volumes listed in Table 3. Table 3: Vancomycin Strength, Diluent Volume and Vancomycin Concentration after Reconstitution. The Grape-Flavored Diluent used to reconstitute the oral solution contains: citric Acid (anhydrous), D&C Yellow 10, FD & C Red No 40, Grape Flavor 501417C, Methyl Paraben, Propylene Glycol, Propyl Paraben, Purified Water, Sucralose.</Description>
</NDC>
<NDC>
<NDCCode>59088-336-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-336-00) * 1 TUBE in 1 KIT > 118 mL in 1 TUBE (59088-333-08) * 1 BOX in 1 KIT > 1 in 1 BOX (30707387763634) * 1 TUBE in 1 KIT > 80 g in 1 TUBE (67877-251-80)</PackageDescription>
<NDC11Code>59088-0336-00</NDC11Code>
<ProductNDC>59088-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Silapak</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide Cream, Dimethicone Cream</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088042</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-09-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-363-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-363-00) * 80 g in 1 TUBE (67877-251-80) * 1 in 1 PACKAGE (731477861930)</PackageDescription>
<NDC11Code>59088-0363-00</NDC11Code>
<ProductNDC>59088-363</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Silazone Pak</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088042</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-08-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-367-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-367-00) * 1 TUBE in 1 KIT > 80 g in 1 TUBE (67877-251-80) * 1 TUBE in 1 KIT > 118 mL in 1 TUBE (59088-333-08)</PackageDescription>
<NDC11Code>59088-0367-00</NDC11Code>
<ProductNDC>59088-367</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Silapak</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide Cream Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088042</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-08-17</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>