{
"NDC": [
{
"NDCCode": "72519-105-21",
"PackageDescription": "30 mL in 1 BOTTLE, DISPENSING (72519-105-21) ",
"NDC11Code": "72519-0105-21",
"ProductNDC": "72519-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xceptol Pain",
"ProprietaryNameSuffix": "Unscented",
"NonProprietaryName": "Tea Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "XCEPTOR LLC",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N",
"IndicationAndUsage": "TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS."
},
{
"NDCCode": "72519-105-11",
"PackageDescription": "1 mL in 1 PACKET (72519-105-11) ",
"NDC11Code": "72519-0105-11",
"ProductNDC": "72519-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xceptol Pain",
"ProprietaryNameSuffix": "Unscented",
"NonProprietaryName": "Tea Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "XCEPTOR LLC",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N",
"IndicationAndUsage": "TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS."
},
{
"NDCCode": "72519-105-22",
"PackageDescription": "50 mL in 1 BOTTLE, DISPENSING (72519-105-22) ",
"NDC11Code": "72519-0105-22",
"ProductNDC": "72519-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xceptol Pain",
"ProprietaryNameSuffix": "Unscented",
"NonProprietaryName": "Tea Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "XCEPTOR LLC",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N",
"IndicationAndUsage": "TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS."
},
{
"NDCCode": "72519-101-21",
"PackageDescription": "30 mL in 1 BOTTLE, DISPENSING (72519-101-21) ",
"NDC11Code": "72519-0101-21",
"ProductNDC": "72519-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xceptor Pain",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181004",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "XCEPTOR LLC",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190309",
"SamplePackage": "N",
"IndicationAndUsage": "TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS."
},
{
"NDCCode": "72519-102-21",
"PackageDescription": "30 mL in 1 BOTTLE, DISPENSING (72519-102-21) ",
"NDC11Code": "72519-0102-21",
"ProductNDC": "72519-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xceptor Cbd Pain",
"ProprietaryNameSuffix": "Unscented",
"NonProprietaryName": "Tea Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181004",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "XCEPTOR LLC",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190309",
"SamplePackage": "N",
"IndicationAndUsage": "TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS."
},
{
"NDCCode": "72519-103-21",
"PackageDescription": "30 mL in 1 BOTTLE, DISPENSING (72519-103-21) ",
"NDC11Code": "72519-0103-21",
"ProductNDC": "72519-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xceptor Cbd Pain",
"ProprietaryNameSuffix": "Lavender",
"NonProprietaryName": "Tea Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181004",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "XCEPTOR LLC",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190309",
"SamplePackage": "N",
"IndicationAndUsage": "TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS."
},
{
"NDCCode": "72519-104-21",
"PackageDescription": "30 mL in 1 BOTTLE, DISPENSING (72519-104-21) ",
"NDC11Code": "72519-0104-21",
"ProductNDC": "72519-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xceptor Cbd Pain",
"ProprietaryNameSuffix": "Menthol",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190311",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "XCEPTOR LLC",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190311",
"SamplePackage": "N",
"IndicationAndUsage": "TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS."
},
{
"NDCCode": "42195-105-06",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (42195-105-06) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "42195-0105-06",
"ProductNDC": "42195-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Decadron Dp",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088237",
"LabelerName": "Xspire Pharma, LLC",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "60687-105-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-105-21) / 1 TABLET in 1 BLISTER PACK (60687-105-11) ",
"NDC11Code": "60687-0105-21",
"ProductNDC": "60687-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone Acetate",
"NonProprietaryName": "Medroxyprogesterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040159",
"LabelerName": "American Health Packaging",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160419",
"SamplePackage": "N",
"IndicationAndUsage": "Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.",
"Description": "Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate."
},
{
"NDCCode": "67046-105-21",
"PackageDescription": "21 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-21)",
"NDC11Code": "67046-0105-21",
"ProductNDC": "67046-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078597",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .",
"Description": "Divalproex sodium is a stable coordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure: Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets: colloidal silicon dioxide, corn starch, povidone, pregelatinized maize starch, hypromellose, titanium dioxide, triacetin, methacrylic acid copolymer type C, talc, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, and sodium lauryl sulfate. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. In addition, individual tablets contain. 125 mg tablets: FD&C Red #40, and FD&C Blue #2. 250 mg tablets: FD&C Yellow #6, and iron oxide yellow. 500 mg tablets: D&C Red #30, FD&C Blue #2, and iron oxide red."
},
{
"NDCCode": "71585-105-21",
"PackageDescription": "88 mL in 1 TUBE (71585-105-21) ",
"NDC11Code": "71585-0105-21",
"ProductNDC": "71585-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Premium Sunscreen",
"ProprietaryNameSuffix": "Spf-30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170829",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SALT AND STONE",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170829",
"SamplePackage": "N",
"IndicationAndUsage": "HELPS PREVENT SUNBURN."
},
{
"NDCCode": "73797-105-14",
"PackageDescription": "118.28 mL in 1 BOTTLE, PLASTIC (73797-105-14) ",
"NDC11Code": "73797-0105-14",
"ProductNDC": "73797-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Creme21 Antibacterial Ultra Protect Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200718",
"EndMarketingDate": "20220826",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Creme 21 GmbH",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "7",
"StrengthUnit": "mL/10mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200718",
"EndMarketingDatePackage": "20220826",
"SamplePackage": "N"
},
{
"NDCCode": "74653-105-21",
"PackageDescription": "80 mL in 1 BOTTLE (74653-105-21) ",
"NDC11Code": "74653-0105-21",
"ProductNDC": "74653-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Micro Guard 24 Hour Surface And Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200609",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Meroven Llc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 surfaces and hand sanitizer to decrease bacteria on the skin and surfaces, 2 recommended for repeated use, 3 for use when soap and water are not available."
},
{
"NDCCode": "74957-105-21",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (74957-105-21) ",
"NDC11Code": "74957-0105-21",
"ProductNDC": "74957-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200612",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SVEDA Organics",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200612",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "83655-105-21",
"PackageDescription": "40 PATCH in 1 CARTON (83655-105-21) / .25 g in 1 PATCH",
"NDC11Code": "83655-0105-21",
"ProductNDC": "83655-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laboflex Acne Spot Care",
"NonProprietaryName": "Salicylic Acid 0.5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230927",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "Laboflex, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230927",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
},
{
"NDCCode": "84789-105-21",
"PackageDescription": "5 g in 1 BOTTLE (84789-105-21) ",
"NDC11Code": "84789-0105-21",
"ProductNDC": "84789-105",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cjc-1295",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240929",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Hangzhou XinHan Biopharma Co., Ltd.",
"SubstanceName": "CJC-1295",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-SEP-24"
},
{
"NDCCode": "0143-9666-06",
"PackageDescription": "6 CONTAINER in 1 CARTON (0143-9666-06) / 200 mL in 1 CONTAINER (0143-9666-01) ",
"NDC11Code": "00143-9666-06",
"ProductNDC": "0143-9666",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078764",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9667-06",
"PackageDescription": "6 CONTAINER in 1 CARTON (0143-9667-06) / 100 mL in 1 CONTAINER (0143-9667-01) ",
"NDC11Code": "00143-9667-06",
"ProductNDC": "0143-9667",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078764",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9668-06",
"PackageDescription": "6 CONTAINER in 1 CARTON (0143-9668-06) / 200 mL in 1 CONTAINER (0143-9668-01) ",
"NDC11Code": "00143-9668-06",
"ProductNDC": "0143-9668",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078698",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9668-10",
"PackageDescription": "10 CONTAINER in 1 CARTON (0143-9668-10) / 200 mL in 1 CONTAINER (0143-9668-01) ",
"NDC11Code": "00143-9668-10",
"ProductNDC": "0143-9668",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078698",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9669-06",
"PackageDescription": "6 CONTAINER in 1 CARTON (0143-9669-06) / 100 mL in 1 CONTAINER (0143-9669-01) ",
"NDC11Code": "00143-9669-06",
"ProductNDC": "0143-9669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078698",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9669-10",
"PackageDescription": "10 CONTAINER in 1 CARTON (0143-9669-10) / 100 mL in 1 CONTAINER (0143-9669-01) ",
"NDC11Code": "00143-9669-10",
"ProductNDC": "0143-9669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078698",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9899-91",
"PackageDescription": "6 VIAL in 1 CARTON (0143-9899-91) / 100 mL in 1 VIAL (0143-9899-01) ",
"NDC11Code": "00143-9899-91",
"ProductNDC": "0143-9899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076736",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050823",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0228-2778-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2778-11) ",
"NDC11Code": "00228-2778-11",
"ProductNDC": "0228-2778",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078494",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070810",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0228-2779-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2779-11) ",
"NDC11Code": "00228-2779-11",
"ProductNDC": "0228-2779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078494",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070810",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0228-2780-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2780-11) ",
"NDC11Code": "00228-2780-11",
"ProductNDC": "0228-2780",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078494",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070810",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0228-2781-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2781-11) ",
"NDC11Code": "00228-2781-11",
"ProductNDC": "0228-2781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078494",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070810",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0409-4196-05",
"PackageDescription": "6 POUCH in 1 CASE (0409-4196-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG",
"NDC11Code": "00409-4196-05",
"ProductNDC": "0409-4196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Potassium Acetate, Phosphoric Acid, And Magnesium Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017789",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; POTASSIUM ACETATE; PHOSPHORIC ACID; MAGNESIUM ACETATE",
"StrengthNumber": "252; 329; 252; 140; 154; 182; 56; 280; 448; 343; 105; 300; 147; 31; 448; 234; 128; 40; 21",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0527-4116-37",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-37) ",
"NDC11Code": "00527-4116-37",
"ProductNDC": "0527-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212026",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0527-4116-41",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-41) ",
"NDC11Code": "00527-4116-41",
"ProductNDC": "0527-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212026",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72519-105-21</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DISPENSING (72519-105-21) </PackageDescription>
<NDC11Code>72519-0105-21</NDC11Code>
<ProductNDC>72519-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xceptol Pain</ProprietaryName>
<ProprietaryNameSuffix>Unscented</ProprietaryNameSuffix>
<NonProprietaryName>Tea Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>XCEPTOR LLC</LabelerName>
<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72519-105-11</NDCCode>
<PackageDescription>1 mL in 1 PACKET (72519-105-11) </PackageDescription>
<NDC11Code>72519-0105-11</NDC11Code>
<ProductNDC>72519-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xceptol Pain</ProprietaryName>
<ProprietaryNameSuffix>Unscented</ProprietaryNameSuffix>
<NonProprietaryName>Tea Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>XCEPTOR LLC</LabelerName>
<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72519-105-22</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, DISPENSING (72519-105-22) </PackageDescription>
<NDC11Code>72519-0105-22</NDC11Code>
<ProductNDC>72519-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xceptol Pain</ProprietaryName>
<ProprietaryNameSuffix>Unscented</ProprietaryNameSuffix>
<NonProprietaryName>Tea Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>XCEPTOR LLC</LabelerName>
<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72519-101-21</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DISPENSING (72519-101-21) </PackageDescription>
<NDC11Code>72519-0101-21</NDC11Code>
<ProductNDC>72519-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xceptor Pain</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181004</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>XCEPTOR LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72519-102-21</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DISPENSING (72519-102-21) </PackageDescription>
<NDC11Code>72519-0102-21</NDC11Code>
<ProductNDC>72519-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xceptor Cbd Pain</ProprietaryName>
<ProprietaryNameSuffix>Unscented</ProprietaryNameSuffix>
<NonProprietaryName>Tea Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181004</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>XCEPTOR LLC</LabelerName>
<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72519-103-21</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DISPENSING (72519-103-21) </PackageDescription>
<NDC11Code>72519-0103-21</NDC11Code>
<ProductNDC>72519-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xceptor Cbd Pain</ProprietaryName>
<ProprietaryNameSuffix>Lavender</ProprietaryNameSuffix>
<NonProprietaryName>Tea Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181004</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>XCEPTOR LLC</LabelerName>
<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72519-104-21</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DISPENSING (72519-104-21) </PackageDescription>
<NDC11Code>72519-0104-21</NDC11Code>
<ProductNDC>72519-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xceptor Cbd Pain</ProprietaryName>
<ProprietaryNameSuffix>Menthol</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190311</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>XCEPTOR LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42195-105-06</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (42195-105-06) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42195-0105-06</NDC11Code>
<ProductNDC>42195-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Decadron Dp</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088237</ApplicationNumber>
<LabelerName>Xspire Pharma, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>60687-105-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-105-21) / 1 TABLET in 1 BLISTER PACK (60687-105-11) </PackageDescription>
<NDC11Code>60687-0105-21</NDC11Code>
<ProductNDC>60687-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040159</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
<Description>Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>67046-105-21</NDCCode>
<PackageDescription>21 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-21)</PackageDescription>
<NDC11Code>67046-0105-21</NDC11Code>
<ProductNDC>67046-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078597</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .</IndicationAndUsage>
<Description>Divalproex sodium is a stable coordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure: Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets: colloidal silicon dioxide, corn starch, povidone, pregelatinized maize starch, hypromellose, titanium dioxide, triacetin, methacrylic acid copolymer type C, talc, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, and sodium lauryl sulfate. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. In addition, individual tablets contain. 125 mg tablets: FD&C Red #40, and FD&C Blue #2. 250 mg tablets: FD&C Yellow #6, and iron oxide yellow. 500 mg tablets: D&C Red #30, FD&C Blue #2, and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>71585-105-21</NDCCode>
<PackageDescription>88 mL in 1 TUBE (71585-105-21) </PackageDescription>
<NDC11Code>71585-0105-21</NDC11Code>
<ProductNDC>71585-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Premium Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf-30</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170829</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SALT AND STONE</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HELPS PREVENT SUNBURN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73797-105-14</NDCCode>
<PackageDescription>118.28 mL in 1 BOTTLE, PLASTIC (73797-105-14) </PackageDescription>
<NDC11Code>73797-0105-14</NDC11Code>
<ProductNDC>73797-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Creme21 Antibacterial Ultra Protect Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200718</StartMarketingDate>
<EndMarketingDate>20220826</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Creme 21 GmbH</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mL/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200718</StartMarketingDatePackage>
<EndMarketingDatePackage>20220826</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74653-105-21</NDCCode>
<PackageDescription>80 mL in 1 BOTTLE (74653-105-21) </PackageDescription>
<NDC11Code>74653-0105-21</NDC11Code>
<ProductNDC>74653-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Micro Guard 24 Hour Surface And Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Meroven Llc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 surfaces and hand sanitizer to decrease bacteria on the skin and surfaces, 2 recommended for repeated use, 3 for use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74957-105-21</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (74957-105-21) </PackageDescription>
<NDC11Code>74957-0105-21</NDC11Code>
<ProductNDC>74957-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200612</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SVEDA Organics</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83655-105-21</NDCCode>
<PackageDescription>40 PATCH in 1 CARTON (83655-105-21) / .25 g in 1 PATCH</PackageDescription>
<NDC11Code>83655-0105-21</NDC11Code>
<ProductNDC>83655-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laboflex Acne Spot Care</ProprietaryName>
<NonProprietaryName>Salicylic Acid 0.5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Laboflex, Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84789-105-21</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (84789-105-21) </PackageDescription>
<NDC11Code>84789-0105-21</NDC11Code>
<ProductNDC>84789-105</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cjc-1295</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240929</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Hangzhou XinHan Biopharma Co., Ltd.</LabelerName>
<SubstanceName>CJC-1295</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-SEP-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0143-9666-06</NDCCode>
<PackageDescription>6 CONTAINER in 1 CARTON (0143-9666-06) / 200 mL in 1 CONTAINER (0143-9666-01) </PackageDescription>
<NDC11Code>00143-9666-06</NDC11Code>
<ProductNDC>0143-9666</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078764</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0143-9667-06</NDCCode>
<PackageDescription>6 CONTAINER in 1 CARTON (0143-9667-06) / 100 mL in 1 CONTAINER (0143-9667-01) </PackageDescription>
<NDC11Code>00143-9667-06</NDC11Code>
<ProductNDC>0143-9667</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078764</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0143-9668-06</NDCCode>
<PackageDescription>6 CONTAINER in 1 CARTON (0143-9668-06) / 200 mL in 1 CONTAINER (0143-9668-01) </PackageDescription>
<NDC11Code>00143-9668-06</NDC11Code>
<ProductNDC>0143-9668</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078698</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0143-9668-10</NDCCode>
<PackageDescription>10 CONTAINER in 1 CARTON (0143-9668-10) / 200 mL in 1 CONTAINER (0143-9668-01) </PackageDescription>
<NDC11Code>00143-9668-10</NDC11Code>
<ProductNDC>0143-9668</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078698</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0143-9669-06</NDCCode>
<PackageDescription>6 CONTAINER in 1 CARTON (0143-9669-06) / 100 mL in 1 CONTAINER (0143-9669-01) </PackageDescription>
<NDC11Code>00143-9669-06</NDC11Code>
<ProductNDC>0143-9669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078698</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0143-9669-10</NDCCode>
<PackageDescription>10 CONTAINER in 1 CARTON (0143-9669-10) / 100 mL in 1 CONTAINER (0143-9669-01) </PackageDescription>
<NDC11Code>00143-9669-10</NDC11Code>
<ProductNDC>0143-9669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078698</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0143-9899-91</NDCCode>
<PackageDescription>6 VIAL in 1 CARTON (0143-9899-91) / 100 mL in 1 VIAL (0143-9899-01) </PackageDescription>
<NDC11Code>00143-9899-91</NDC11Code>
<ProductNDC>0143-9899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076736</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0228-2778-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2778-11) </PackageDescription>
<NDC11Code>00228-2778-11</NDC11Code>
<ProductNDC>0228-2778</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078494</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>0228-2779-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2779-11) </PackageDescription>
<NDC11Code>00228-2779-11</NDC11Code>
<ProductNDC>0228-2779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078494</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>0228-2780-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2780-11) </PackageDescription>
<NDC11Code>00228-2780-11</NDC11Code>
<ProductNDC>0228-2780</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078494</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>0228-2781-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2781-11) </PackageDescription>
<NDC11Code>00228-2781-11</NDC11Code>
<ProductNDC>0228-2781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078494</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>0409-4196-05</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0409-4196-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4196-05</NDC11Code>
<ProductNDC>0409-4196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Potassium Acetate, Phosphoric Acid, And Magnesium Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017789</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; POTASSIUM ACETATE; PHOSPHORIC ACID; MAGNESIUM ACETATE</SubstanceName>
<StrengthNumber>252; 329; 252; 140; 154; 182; 56; 280; 448; 343; 105; 300; 147; 31; 448; 234; 128; 40; 21</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0527-4116-37</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-37) </PackageDescription>
<NDC11Code>00527-4116-37</NDC11Code>
<ProductNDC>0527-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212026</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>0527-4116-41</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-41) </PackageDescription>
<NDC11Code>00527-4116-41</NDC11Code>
<ProductNDC>0527-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212026</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
</NDCList>