{
"NDC": [
{
"NDCCode": "60760-914-05",
"PackageDescription": "5 POUCH in 1 CARTON (60760-914-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH",
"NDC11Code": "60760-0914-05",
"ProductNDC": "60760-914",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20110126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077062",
"LabelerName": "St. Marys Medical Park Pharmacy",
"SubstanceName": "FENTANYL",
"StrengthNumber": "100",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62032-914-01",
"PackageDescription": "1 KIT in 1 KIT (62032-914-01) * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 TUBE (62032-140-05) * 59 mL in 1 BOTTLE, PLASTIC * 59 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0914-01",
"ProductNDC": "62032-914",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Obagi Nu-derm System Normal-oily Skin Transformation Trial",
"NonProprietaryName": "Hydroquinone, Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210625",
"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": "67091-914-05",
"PackageDescription": "5 PATCH in 1 CARTON (67091-914-05) / 1 PATCH in 1 PATCH",
"NDC11Code": "67091-0914-05",
"ProductNDC": "67091-914",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Winco Cold And Hot Medicated Patch Large",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200911",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "WINCO FOODS, LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200911",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. -open pouch and remove patch. -carefully peel off protective backing and apply sticky side to affected area. -adults and children 12 years of age and older: 1 do not wear patch for more than 8 hours, 2 apply to affected area no more than 3 times daily."
},
{
"NDCCode": "67457-914-05",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (67457-914-05) / 10 mL in 1 VIAL, GLASS (67457-914-00) ",
"NDC11Code": "67457-0914-05",
"ProductNDC": "67457-914",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultiva",
"NonProprietaryName": "Remifentanil Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200415",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020630",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "REMIFENTANIL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200415",
"SamplePackage": "N",
"IndicationAndUsage": "ULTIVA is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.",
"Description": "ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3."
},
{
"NDCCode": "68428-914-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-914-05)",
"NDC11Code": "68428-0914-05",
"ProductNDC": "68428-914",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chromium Oxydatum",
"NonProprietaryName": "Chromic Oxide",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110727",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CHROMIC OXIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68462-914-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-914-05) ",
"NDC11Code": "68462-0914-05",
"ProductNDC": "68462-914",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Hydrochloride",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216350",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241230",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine hydrochloride, USP is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazine-ethanol dihydrochloride. The structural formula is represented below. Molecular Formula: C22H26F3N3OS·2HCl Molecular Weight: 510.44. Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27 (2.5 mg tablet), D&C Yellow No. 10 (1 mg and 5 mg tablet), FD&C Blue No. 2 (1 mg, 2.5 mg and 5 mg tablet), FD&C Red No. 40 (10 mg tablet), FD&C Yellow No. 6 (1 mg, 5 mg and 10 mg tablet), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water, and titanium dioxide."
},
{
"NDCCode": "71101-914-05",
"PackageDescription": "5 g in 1 CARTON (71101-914-05) ",
"NDC11Code": "71101-0914-05",
"ProductNDC": "71101-914",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healthwise Lidocaine And Menthol Pain Relief",
"NonProprietaryName": "Lidocaine And Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Veridian Healthcare",
"SubstanceName": "LIDOCAINE; MENTHOL",
"StrengthNumber": "4; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief minor pain."
},
{
"NDCCode": "76420-914-05",
"PackageDescription": "50 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "76420-0914-05",
"ProductNDC": "76420-914",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen Tablet Extended Release",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215486",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-02-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250127",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache."
},
{
"NDCCode": "84756-914-05",
"PackageDescription": "100 g in 1 BOX (84756-914-05) ",
"NDC11Code": "84756-0914-05",
"ProductNDC": "84756-914",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Caffeine Eye Cream",
"NonProprietaryName": "Trstay Caffeine Eye Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "60760-201-05",
"PackageDescription": "5 POUCH in 1 BAG (60760-201-05) / 1 g in 1 POUCH",
"NDC11Code": "60760-0201-05",
"ProductNDC": "60760-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200675",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"Description": "Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium."
},
{
"NDCCode": "60760-396-05",
"PackageDescription": "5 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-396-05) ",
"NDC11Code": "60760-0396-05",
"ProductNDC": "60760-396",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091672",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181030",
"SamplePackage": "N"
},
{
"NDCCode": "60760-521-05",
"PackageDescription": "5 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-521-05) ",
"NDC11Code": "60760-0521-05",
"ProductNDC": "60760-521",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076048",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N"
},
{
"NDCCode": "60760-583-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (60760-583-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "60760-0583-05",
"ProductNDC": "60760-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207444",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190912",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children.",
"Description": "Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin ophthalmic solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: Benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. Molecular Weight = 467.52. Molecular Formula: C 18H 37N 5O 9. Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine."
},
{
"NDCCode": "60760-657-05",
"PackageDescription": "5 POUCH in 1 BAG (60760-657-05) / 14 g in 1 POUCH",
"NDC11Code": "60760-0657-05",
"ProductNDC": "60760-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine 5%",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230830",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "60760-693-05",
"PackageDescription": "5 CAPSULE in 1 BOTTLE, PLASTIC (60760-693-05)",
"NDC11Code": "60760-0693-05",
"ProductNDC": "60760-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065243",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "60760-880-05",
"PackageDescription": "5 POUCH in 1 BAG (60760-880-05) / 1 g in 1 POUCH",
"NDC11Code": "60760-0880-05",
"ProductNDC": "60760-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20200204",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020612",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200204",
"SamplePackage": "N",
"IndicationAndUsage": "LIDOCAINE PATCH 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "LIDOCAINE PATCH 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non‑woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2‑(diethylamino)‑N‑(2,6‑ dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, and urea."
},
{
"NDCCode": "60760-911-05",
"PackageDescription": "5 POUCH in 1 CARTON (60760-911-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH",
"NDC11Code": "60760-0911-05",
"ProductNDC": "60760-911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20110126",
"EndMarketingDate": "20190331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077062",
"LabelerName": "St. Marys Medical Park Pharmacy",
"SubstanceName": "FENTANYL",
"StrengthNumber": "25",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
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"LastUpdate": "2019-04-02",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
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"LabelerName": "St. Marys Medical Park Pharmacy",
"SubstanceName": "FENTANYL",
"StrengthNumber": "50",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
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"LastUpdate": "2019-06-04",
"PackageNdcExcludeFlag": "N",
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{
"NDCCode": "60760-917-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (60760-917-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "60760-0917-05",
"ProductNDC": "60760-917",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20250129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076513",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:.",
"Description": "Ofloxacin ophthalmic solution, USP 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use."
},
{
"NDCCode": "60760-970-05",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (60760-970-05) / 5 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "60760-0970-05",
"ProductNDC": "60760-970",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20241122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078559",
"LabelerName": "ST. MARY'S MEDICAL PARK PHARMACY",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-24",
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"IndicationAndUsage": "Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below. * Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name:(±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo- 7Hpyrido [1,2,3- de]-1,4 benzoxazine-6-carboxylic acid. Contains: Active:ofloxacin 0.3% (3 mg/mL). Preservative:benzalkonium chloride (0.005%). Inactives:sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution is unbuffered and formulated with a pH of 6.4 (range 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure."
},
{
"NDCCode": "0008-1040-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05) ",
"NDC11Code": "00008-1040-05",
"ProductNDC": "0008-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100301",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100301",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1041-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1041-05) ",
"NDC11Code": "00008-1041-05",
"ProductNDC": "0008-1041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20010701",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1042-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1042-05) ",
"NDC11Code": "00008-1042-05",
"ProductNDC": "0008-1042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20010701",
"EndMarketingDatePackage": "20251031",
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"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "16714-187-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16714-187-01) ",
"NDC11Code": "16714-0187-01",
"ProductNDC": "16714-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208691",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211018",
"SamplePackage": "N",
"IndicationAndUsage": "Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2."
},
{
"NDCCode": "16714-188-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16714-188-01) ",
"NDC11Code": "16714-0188-01",
"ProductNDC": "16714-188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208691",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211018",
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"IndicationAndUsage": "Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2."
},
{
"NDCCode": "16714-189-01",
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"NDC11Code": "16714-0189-01",
"ProductNDC": "16714-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208691",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20211018",
"SamplePackage": "N",
"IndicationAndUsage": "Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2."
},
{
"NDCCode": "41250-914-11",
"PackageDescription": "1368 g in 1 BOTTLE, PLASTIC (41250-914-11) ",
"NDC11Code": "41250-0914-11",
"ProductNDC": "41250-914",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer Natural Fiber",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20170314",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "MEIJER DISTRIBUTION INC",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": "3.4",
"StrengthUnit": "g/12g",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170314",
"SamplePackage": "N",
"IndicationAndUsage": "▪for relief of occasional constipation (irregularity). ▪Generally produces bowel movement in 12-72 hours."
},
{
"NDCCode": "41250-914-72",
"PackageDescription": "861 g in 1 BOTTLE, PLASTIC (41250-914-72) ",
"NDC11Code": "41250-0914-72",
"ProductNDC": "41250-914",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer Natural Fiber",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20170314",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "MEIJER DISTRIBUTION INC",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": "3.4",
"StrengthUnit": "g/12g",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170314",
"SamplePackage": "N",
"IndicationAndUsage": "▪for relief of occasional constipation (irregularity). ▪Generally produces bowel movement in 12-72 hours."
},
{
"NDCCode": "42291-914-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (42291-914-50) ",
"NDC11Code": "42291-0914-50",
"ProductNDC": "42291-914",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075079",
"LabelerName": "AvKARE",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220930",
"SamplePackage": "N",
"IndicationAndUsage": "Oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).",
"Description": "Each scored oxybutynin chloride tablet contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22H 31NO 3HCl. The structural formula appears below:. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets also contain: FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Oxybutynin Chloride Tablets are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. The product meets USP Dissolution Test 2."
},
{
"NDCCode": "43269-914-16",
"PackageDescription": "500 mL in 1 BOTTLE, PUMP (43269-914-16)",
"NDC11Code": "43269-0914-16",
"ProductNDC": "43269-914",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Foaming Hand Wash Mischievous Orange",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150603",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/13mL",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>60760-914-05</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (60760-914-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH</PackageDescription>
<NDC11Code>60760-0914-05</NDC11Code>
<ProductNDC>60760-914</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20110126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077062</ApplicationNumber>
<LabelerName>St. Marys Medical Park Pharmacy</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62032-914-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (62032-914-01) * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 TUBE (62032-140-05) * 59 mL in 1 BOTTLE, PLASTIC * 59 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>62032-0914-01</NDC11Code>
<ProductNDC>62032-914</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Obagi Nu-derm System Normal-oily Skin Transformation Trial</ProprietaryName>
<NonProprietaryName>Hydroquinone, Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210625</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>67091-914-05</NDCCode>
<PackageDescription>5 PATCH in 1 CARTON (67091-914-05) / 1 PATCH in 1 PATCH</PackageDescription>
<NDC11Code>67091-0914-05</NDC11Code>
<ProductNDC>67091-914</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Winco Cold And Hot Medicated Patch Large</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>WINCO FOODS, LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. -open pouch and remove patch. -carefully peel off protective backing and apply sticky side to affected area. -adults and children 12 years of age and older: 1 do not wear patch for more than 8 hours, 2 apply to affected area no more than 3 times daily.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67457-914-05</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (67457-914-05) / 10 mL in 1 VIAL, GLASS (67457-914-00) </PackageDescription>
<NDC11Code>67457-0914-05</NDC11Code>
<ProductNDC>67457-914</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultiva</ProprietaryName>
<NonProprietaryName>Remifentanil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200415</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020630</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>REMIFENTANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTIVA is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.</IndicationAndUsage>
<Description>ULTIVA (remifentanil hydrochloride) for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. ULTIVA is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of ULTIVA are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of ULTIVA ranges from 2.5 to 3.5. Remifentanil hydrochloride has a pKa of 7.07. Remifentanil hydrochloride has an n-octanol:water partition coefficient of 17.9 at pH 7.3.</Description>
</NDC>
<NDC>
<NDCCode>68428-914-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-914-05)</PackageDescription>
<NDC11Code>68428-0914-05</NDC11Code>
<ProductNDC>68428-914</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chromium Oxydatum</ProprietaryName>
<NonProprietaryName>Chromic Oxide</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110727</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CHROMIC OXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68462-914-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-914-05) </PackageDescription>
<NDC11Code>68462-0914-05</NDC11Code>
<ProductNDC>68462-914</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216350</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine hydrochloride, USP is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazine-ethanol dihydrochloride. The structural formula is represented below. Molecular Formula: C22H26F3N3OS·2HCl Molecular Weight: 510.44. Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27 (2.5 mg tablet), D&C Yellow No. 10 (1 mg and 5 mg tablet), FD&C Blue No. 2 (1 mg, 2.5 mg and 5 mg tablet), FD&C Red No. 40 (10 mg tablet), FD&C Yellow No. 6 (1 mg, 5 mg and 10 mg tablet), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71101-914-05</NDCCode>
<PackageDescription>5 g in 1 CARTON (71101-914-05) </PackageDescription>
<NDC11Code>71101-0914-05</NDC11Code>
<ProductNDC>71101-914</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healthwise Lidocaine And Menthol Pain Relief</ProprietaryName>
<NonProprietaryName>Lidocaine And Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Veridian Healthcare</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>4; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief minor pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-914-05</NDCCode>
<PackageDescription>50 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>76420-0914-05</NDC11Code>
<ProductNDC>76420-914</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablet Extended Release</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215486</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For Arthritis Pain. temporarily relieves minor aches and pains due to: 1 minor pain of arthritis, 2 muscular aches, 3 backache, 4 premenstrual and menstrual cramps, 5 the common cold, 6 headache, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-914-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84756-914-05) </PackageDescription>
<NDC11Code>84756-0914-05</NDC11Code>
<ProductNDC>84756-914</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Caffeine Eye Cream</ProprietaryName>
<NonProprietaryName>Trstay Caffeine Eye Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60760-201-05</NDCCode>
<PackageDescription>5 POUCH in 1 BAG (60760-201-05) / 1 g in 1 POUCH</PackageDescription>
<NDC11Code>60760-0201-05</NDC11Code>
<ProductNDC>60760-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200675</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium.</Description>
</NDC>
<NDC>
<NDCCode>60760-396-05</NDCCode>
<PackageDescription>5 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-396-05) </PackageDescription>
<NDC11Code>60760-0396-05</NDC11Code>
<ProductNDC>60760-396</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091672</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-521-05</NDCCode>
<PackageDescription>5 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-521-05) </PackageDescription>
<NDC11Code>60760-0521-05</NDC11Code>
<ProductNDC>60760-521</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076048</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-583-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (60760-583-05) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>60760-0583-05</NDC11Code>
<ProductNDC>60760-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207444</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children.</IndicationAndUsage>
<Description>Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin ophthalmic solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: Benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. Molecular Weight = 467.52. Molecular Formula: C 18H 37N 5O 9. Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.</Description>
</NDC>
<NDC>
<NDCCode>60760-657-05</NDCCode>
<PackageDescription>5 POUCH in 1 BAG (60760-657-05) / 14 g in 1 POUCH</PackageDescription>
<NDC11Code>60760-0657-05</NDC11Code>
<ProductNDC>60760-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine 5%</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>60760-693-05</NDCCode>
<PackageDescription>5 CAPSULE in 1 BOTTLE, PLASTIC (60760-693-05)</PackageDescription>
<NDC11Code>60760-0693-05</NDC11Code>
<ProductNDC>60760-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065243</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60760-880-05</NDCCode>
<PackageDescription>5 POUCH in 1 BAG (60760-880-05) / 1 g in 1 POUCH</PackageDescription>
<NDC11Code>60760-0880-05</NDC11Code>
<ProductNDC>60760-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20200204</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020612</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIDOCAINE PATCH 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>LIDOCAINE PATCH 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non‑woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2‑(diethylamino)‑N‑(2,6‑ dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, and urea.</Description>
</NDC>
<NDC>
<NDCCode>60760-911-05</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (60760-911-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH</PackageDescription>
<NDC11Code>60760-0911-05</NDC11Code>
<ProductNDC>60760-911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20110126</StartMarketingDate>
<EndMarketingDate>20190331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077062</ApplicationNumber>
<LabelerName>St. Marys Medical Park Pharmacy</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110126</StartMarketingDatePackage>
<EndMarketingDatePackage>20190331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-912-05</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (60760-912-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH</PackageDescription>
<NDC11Code>60760-0912-05</NDC11Code>
<ProductNDC>60760-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20110126</StartMarketingDate>
<EndMarketingDate>20190531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077062</ApplicationNumber>
<LabelerName>St. Marys Medical Park Pharmacy</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110126</StartMarketingDatePackage>
<EndMarketingDatePackage>20190531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-917-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60760-917-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>60760-0917-05</NDC11Code>
<ProductNDC>60760-917</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20250129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076513</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:.</IndicationAndUsage>
<Description>Ofloxacin ophthalmic solution, USP 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use.</Description>
</NDC>
<NDC>
<NDCCode>60760-970-05</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (60760-970-05) / 5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>60760-0970-05</NDC11Code>
<ProductNDC>60760-970</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20241122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078559</ApplicationNumber>
<LabelerName>ST. MARY'S MEDICAL PARK PHARMACY</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below. * Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name:(±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo- 7Hpyrido [1,2,3- de]-1,4 benzoxazine-6-carboxylic acid. Contains: Active:ofloxacin 0.3% (3 mg/mL). Preservative:benzalkonium chloride (0.005%). Inactives:sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution is unbuffered and formulated with a pH of 6.4 (range 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.</Description>
</NDC>
<NDC>
<NDCCode>0008-1040-05</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05) </PackageDescription>
<NDC11Code>00008-1040-05</NDC11Code>
<ProductNDC>0008-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021110</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100301</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-1041-05</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1041-05) </PackageDescription>
<NDC11Code>00008-1041-05</NDC11Code>
<ProductNDC>0008-1041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010701</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021110</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20010701</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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<IndicationAndUsage>Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2.</Description>
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<LastUpdate>2026-05-13</LastUpdate>
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<IndicationAndUsage>Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2.</Description>
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<LastUpdate>2026-05-13</LastUpdate>
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<IndicationAndUsage>Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>▪for relief of occasional constipation (irregularity). ▪Generally produces bowel movement in 12-72 hours.</IndicationAndUsage>
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<IndicationAndUsage>▪for relief of occasional constipation (irregularity). ▪Generally produces bowel movement in 12-72 hours.</IndicationAndUsage>
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<PackageDescription>500 TABLET in 1 BOTTLE (42291-914-50) </PackageDescription>
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<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20220930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075079</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
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<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).</IndicationAndUsage>
<Description>Each scored oxybutynin chloride tablet contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22H 31NO 3HCl. The structural formula appears below:. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets also contain: FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Oxybutynin Chloride Tablets are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. The product meets USP Dissolution Test 2.</Description>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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