{
"NDC": [
{
"NDCCode": "58411-254-80",
"PackageDescription": "2 mL in 1 POUCH (58411-254-80) ",
"NDC11Code": "58411-0254-80",
"ProductNDC": "58411-254",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Ultimate Sun Protection",
"NonProprietaryName": "Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "4255; 1725; 805; 9430",
"StrengthUnit": "mg/50mL; mg/50mL; mg/50mL; mg/50mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N"
},
{
"NDCCode": "58411-254-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-254-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0254-60",
"ProductNDC": "58411-254",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Ultimate Sun Protection",
"NonProprietaryName": "Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "4255; 1725; 805; 9430",
"StrengthUnit": "mg/50mL; mg/50mL; mg/50mL; mg/50mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "58411-254-61",
"PackageDescription": "1 TUBE in 1 CARTON (58411-254-61) > 30 mL in 1 TUBE",
"NDC11Code": "58411-0254-61",
"ProductNDC": "58411-254",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Ultimate Sun Protection",
"NonProprietaryName": "Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "4255; 1725; 805; 9430",
"StrengthUnit": "mg/50mL; mg/50mL; mg/50mL; mg/50mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "58411-254-62",
"PackageDescription": "1 TUBE in 1 CARTON (58411-254-62) > 15 mL in 1 TUBE",
"NDC11Code": "58411-0254-62",
"ProductNDC": "58411-254",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Ultimate Sun Protection",
"NonProprietaryName": "Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "4255; 1725; 805; 9430",
"StrengthUnit": "mg/50mL; mg/50mL; mg/50mL; mg/50mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "58411-142-80",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (58411-142-80) > 132.6 g in 1 BOTTLE, SPRAY",
"NDC11Code": "58411-0142-80",
"ProductNDC": "58411-142",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Ultimate Sun Protection",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3.98; 19.89; 6.63; 3.32; 6.63",
"StrengthUnit": "mg/132.6g; mg/132.6g; mg/132.6g; mg/132.6g; mg/132.6g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140401",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "58411-253-80",
"PackageDescription": "2 mL in 1 POUCH (58411-253-80) ",
"NDC11Code": "58411-0253-80",
"ProductNDC": "58411-253",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Ultimate Sun Protection",
"NonProprietaryName": "Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "8406; 3408; 1590; 18630",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N"
},
{
"NDCCode": "58411-345-61",
"PackageDescription": "1 POUCH in 1 CARTON (58411-345-61) > 1.65 g in 1 POUCH (58411-345-80) ",
"NDC11Code": "58411-0345-61",
"ProductNDC": "58411-345",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Sun Protection Eye",
"NonProprietaryName": "Octinoxate, Octocrylene, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "479; 495; 1749",
"StrengthUnit": "mg/16.5g; mg/16.5g; mg/16.5g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20121201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "58411-346-80",
"PackageDescription": "2.12 g in 1 POUCH (58411-346-80) ",
"NDC11Code": "58411-0346-80",
"ProductNDC": "58411-346",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Urban Environment",
"ProprietaryNameSuffix": "Oil-free Uv Protector",
"NonProprietaryName": "Octinoxate, Octocrylene, And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICA INC.",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "1557; 953; 3971",
"StrengthUnit": "mg/31.77g; mg/31.77g; mg/31.77g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20121001",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "58411-347-80",
"PackageDescription": "2.18 g in 1 POUCH (58411-347-80) ",
"NDC11Code": "58411-0347-80",
"ProductNDC": "58411-347",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Urban Environment Uv Protection",
"NonProprietaryName": "Octinoxate, Octocrylene, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "1583; 1638; 5788",
"StrengthUnit": "mg/54.6g; mg/54.6g; mg/54.6g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20121001",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "24470-951-16",
"PackageDescription": "473 mL in 1 BOTTLE (24470-951-16) ",
"NDC11Code": "24470-0951-16",
"ProductNDC": "24470-951",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide, Sulfur",
"NonProprietaryName": "Sodium Sulfacetamide, Sulfur",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cintex Services, LLC",
"SubstanceName": "SULFUR; SULFACETAMIDE SODIUM",
"StrengthNumber": "40; 80",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each mL contains 80 mg of sodium sulfacetamide and 40 mg of colloidal sulfur in a vehicle consisting of: aloe vera gel, benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "25021-254-08",
"PackageDescription": "1 VIAL in 1 CARTON (25021-254-08) / 8 mL in 1 VIAL",
"NDC11Code": "25021-0254-08",
"ProductNDC": "25021-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213510",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5) .",
"Description": "Docetaxel, USP is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula:. Docetaxel is a white to almost-white, crystalline powder with an empirical formula of C43H53NO14 and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg per mL concentration. Each mL contains 10 mg docetaxel (anhydrous) USP, 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid, USP 23% v/v, dehydrated alcohol, USP and polyethylene glycol 300 NF. Docetaxel Injection is available in multi-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "25021-254-16",
"PackageDescription": "1 VIAL in 1 CARTON (25021-254-16) / 16 mL in 1 VIAL",
"NDC11Code": "25021-0254-16",
"ProductNDC": "25021-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213510",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5) .",
"Description": "Docetaxel, USP is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula:. Docetaxel is a white to almost-white, crystalline powder with an empirical formula of C43H53NO14 and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg per mL concentration. Each mL contains 10 mg docetaxel (anhydrous) USP, 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid, USP 23% v/v, dehydrated alcohol, USP and polyethylene glycol 300 NF. Docetaxel Injection is available in multi-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "27241-254-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (27241-254-01) ",
"NDC11Code": "27241-0254-01",
"ProductNDC": "27241-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Hydrochloride",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217410",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230105",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine hydrochloride tablets, USP are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride USP has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine hydrochloride USP is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Fluphenazine hydrochloride is described chemically as 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl]propyl]-1-piperazineethanol dihydrochloride and its molecular formula is C22H26F3N3OS.2HCl. The molecular structure is shown below. Fluphenazine Hydrochloride Tablets, USP contain 1 mg, 2.5 mg, 5 mg and 10 mg fluphenazine hydrochloride USP per tablet. Inactive ingredients: Aluminum Lake of the colorant FD&C yellow #6 for 2.5 mg, 5 mg and 10 mg only, microcrystalline cellulose, pregelatinized starch, magnesium stearate, lactose monohydrate, hypromellose, polyethylene glycol, polysorbate 80, polydextrose, triacetin, sodium alginate, lecithin (soy), and titanium dioxide. FDA approved dissolution acceptance criterion differ from the USP dissolution test 1."
},
{
"NDCCode": "44523-624-16",
"PackageDescription": "473 mL in 1 BOTTLE (44523-624-16) ",
"NDC11Code": "44523-0624-16",
"ProductNDC": "44523-624",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250127",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BioComp Pharma, Inc.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "80; 40",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250127",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each mL contains 80 mg of sodium sulfacetamide and 40 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, polyethylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "52187-531-16",
"PackageDescription": "473 mL in 1 BOTTLE (52187-531-16) ",
"NDC11Code": "52187-0531-16",
"ProductNDC": "52187-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide, Sulfur",
"NonProprietaryName": "Sodium Sulfacetamide, Sulfur",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200520",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "KMM Pharmaceuticals, LLC",
"SubstanceName": "SULFUR; SULFACETAMIDE SODIUM",
"StrengthNumber": "40; 80",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2020-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200520",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each mL contains 80 mg of sodium sulfacetamide and 40 mg of colloidal sulfur in a vehicle consisting of: aloe vera gel, benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "55111-254-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (55111-254-01) ",
"NDC11Code": "55111-0254-01",
"ProductNDC": "55111-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076649",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "55111-254-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-254-05) ",
"NDC11Code": "55111-0254-05",
"ProductNDC": "55111-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076649",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "55111-254-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (55111-254-10) ",
"NDC11Code": "55111-0254-10",
"ProductNDC": "55111-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076649",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "55111-254-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55111-254-30) ",
"NDC11Code": "55111-0254-30",
"ProductNDC": "55111-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076649",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "55111-254-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-254-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-254-79) ",
"NDC11Code": "55111-0254-78",
"ProductNDC": "55111-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076649",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "58657-469-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (58657-469-16) ",
"NDC11Code": "58657-0469-16",
"ProductNDC": "58657-469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide 8% And Sulfur 4% Cleanser",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Method Pharmaceuticals",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "80; 40",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220215",
"SamplePackage": "N",
"IndicationAndUsage": "SODIUM SULFACETAMIDE 8% - SULFUR 4% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram of sodium sulfacetamide 8% and sulfur 4% cleanser contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a cleanser containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Green Tea Extract, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is."
},
{
"NDCCode": "59572-711-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (59572-711-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "59572-0711-01",
"ProductNDC": "59572-711",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reblozyl",
"NonProprietaryName": "Luspatercept",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191108",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761136",
"LabelerName": "Celgene Corporation",
"SubstanceName": "LUSPATERCEPT",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Erythroid Maturation Agent [EPC], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191108",
"SamplePackage": "N",
"IndicationAndUsage": "REBLOZYL is an erythroid maturation agent indicated for the treatment of: 1 Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions (1.1)., 2 Anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions (1.2)., 3 Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) (1.3)., 4 Limitations of Use: REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia (1.4).",
"Description": "Luspatercept-aamt is an erythroid maturation agent. Luspatercept-aamt is a receptor fusion protein consisting of a modified extracellular domain of the human activin receptor type IIB linked to a human IgG1 Fc domain with a calculated molecular mass of approximately 76 kD. Luspatercept is produced in Chinese hamster ovary cells by recombinant DNA technology. REBLOZYL (luspatercept-aamt) for injection is a sterile, preservative-free, white to off-white, lyophilized powder in single-dose vials for subcutaneous use after reconstitution. Each 25 mg single-dose vial provides nominal 25 mg of luspatercept-aamt and citric acid monohydrate (0.085 mg), polysorbate 80 (0.10 mg), sucrose (45 mg), and tri-sodium citrate dihydrate (1.35 mg) at pH 6.5. After reconstitution with 0.68 mL Sterile Water for Injection USP, the resulting concentration is 25 mg/0.5 mL of luspatercept-aamt and the nominal deliverable volume is 0.5 mL. Each 75 mg single-dose vial provides nominal 75 mg of luspatercept-aamt and citric acid monohydrate (0.254 mg), polysorbate 80 (0.30 mg), sucrose (135 mg), and tri-sodium citrate dihydrate (4.06 mg) at pH 6.5. After reconstitution with 1.6 mL Sterile Water for Injection USP, the resulting concentration is 75 mg/1.5 mL (50 mg/mL) of luspatercept-aamt and the nominal deliverable volume is 1.5 mL."
},
{
"NDCCode": "59572-775-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (59572-775-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "59572-0775-01",
"ProductNDC": "59572-775",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reblozyl",
"NonProprietaryName": "Luspatercept",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191108",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761136",
"LabelerName": "Celgene Corporation",
"SubstanceName": "LUSPATERCEPT",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Erythroid Maturation Agent [EPC], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191108",
"SamplePackage": "N",
"IndicationAndUsage": "REBLOZYL is an erythroid maturation agent indicated for the treatment of: 1 Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions (1.1)., 2 Anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions (1.2)., 3 Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) (1.3)., 4 Limitations of Use: REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia (1.4).",
"Description": "Luspatercept-aamt is an erythroid maturation agent. Luspatercept-aamt is a receptor fusion protein consisting of a modified extracellular domain of the human activin receptor type IIB linked to a human IgG1 Fc domain with a calculated molecular mass of approximately 76 kD. Luspatercept is produced in Chinese hamster ovary cells by recombinant DNA technology. REBLOZYL (luspatercept-aamt) for injection is a sterile, preservative-free, white to off-white, lyophilized powder in single-dose vials for subcutaneous use after reconstitution. Each 25 mg single-dose vial provides nominal 25 mg of luspatercept-aamt and citric acid monohydrate (0.085 mg), polysorbate 80 (0.10 mg), sucrose (45 mg), and tri-sodium citrate dihydrate (1.35 mg) at pH 6.5. After reconstitution with 0.68 mL Sterile Water for Injection USP, the resulting concentration is 25 mg/0.5 mL of luspatercept-aamt and the nominal deliverable volume is 0.5 mL. Each 75 mg single-dose vial provides nominal 75 mg of luspatercept-aamt and citric acid monohydrate (0.254 mg), polysorbate 80 (0.30 mg), sucrose (135 mg), and tri-sodium citrate dihydrate (4.06 mg) at pH 6.5. After reconstitution with 1.6 mL Sterile Water for Injection USP, the resulting concentration is 75 mg/1.5 mL (50 mg/mL) of luspatercept-aamt and the nominal deliverable volume is 1.5 mL."
},
{
"NDCCode": "70529-254-01",
"PackageDescription": "1 KIT in 1 KIT (70529-254-01) * 1 TUBE in 1 CARTON (17478-840-05) > 5 mL in 1 TUBE * .55 mL in 1 POUCH (67777-121-13) ",
"NDC11Code": "70529-0254-01",
"ProductNDC": "70529-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venipuncture Px1",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20160501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040433",
"LabelerName": "IT3 Medical LLC",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160501",
"SamplePackage": "N",
"Description": "Lidocaine HCl 2% Jelly is a sterile, aqueous product that contains a local anesthetic agent and is administered topically. (See INDICATIONS for specific uses.). Lidocaine HCl 2% Jelly contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. Its molecular formula is C14H22N2O HCl and its molecular weight is 270.80. Lidocaine HCl 2% Jelly also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of Lidocaine HCl 2% Jelly 30 mL and 5 mL tubes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust pH between 6.0 to 7.0."
},
{
"NDCCode": "71610-254-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-254-30) ",
"NDC11Code": "71610-0254-30",
"ProductNDC": "71610-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204170",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2019-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190322",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate extended-release tablets, USP are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)].",
"Description": "Zolpidem tartrate extended-release tablets, USP contain zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate extended-release tablets, USP are available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)tartrate (2:1). It has the following structure:. Zolpidem tartrate is a white to off-white crystalline powder that is slightly soluble in water, sparingly soluble in alcohol, and propylene glycol. It has a molecular weight of 764.86. Zolpidem tartrate extended-release tablets, USP consist of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide red, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80. The 12.5 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide yellow, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80.The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, and ammonium hydroxide.It meets USP Dissolution Test 2."
},
{
"NDCCode": "72162-2247-2",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (72162-2247-2) ",
"NDC11Code": "72162-2247-02",
"ProductNDC": "72162-2247",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide 8% And Sulfur 4% Cleanser",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "80; 40",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260319",
"SamplePackage": "N",
"IndicationAndUsage": "SODIUM SULFACETAMIDE 8% - SULFUR 4% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram of sodium sulfacetamide 8% and sulfur 4% cleanser contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a cleanser containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Green Tea Extract, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is."
},
{
"NDCCode": "81672-5051-1",
"PackageDescription": "1 TUBE in 1 PACKAGE (81672-5051-1) / 60 g in 1 TUBE",
"NDC11Code": "81672-5051-01",
"ProductNDC": "81672-5051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vtama",
"NonProprietaryName": "Tapinarof",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215272",
"LabelerName": "Organon LLC",
"SubstanceName": "TAPINAROF",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Aryl Hydrocarbon Receptor Agonist [EPC], Aryl Hydrocarbon Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250528",
"SamplePackage": "N",
"Description": "VTAMA (tapinarof) cream contains tapinarof as the active ingredient. Tapinarof is an aryl hydrocarbon receptor agonist. Tapinarof is a white to pale brown powder. Chemically, tapinarof is 3, 5-dihydroxy-4-isopropyl-trans-stilbene, also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol, with the empirical formula C17H18O2, a molecular weight of 254.32, and the following structural formula. Each gram of VTAMA cream for topical use contains 10 mg of tapinarof in a white to off-white cream. VTAMA cream also contains the following inactive ingredients: benzoic acid, butylated hydroxytoluene, citric acid monohydrate, diethylene glycol monoethyl ether, edetate disodium, emulsifying wax, medium-chain triglycerides, polyoxyl 2 stearyl ether, polyoxyl 20 stearyl ether, polysorbate 80, propylene glycol, purified water, and sodium citrate dihydrate."
},
{
"NDCCode": "82429-126-16",
"PackageDescription": "454 g in 1 BOTTLE, PLASTIC (82429-126-16) ",
"NDC11Code": "82429-0126-16",
"ProductNDC": "82429-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide 8% And Sulfur 4% Cleanser",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230405",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Gabar Health Sciences Corp.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "80; 40",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230405",
"SamplePackage": "N",
"IndicationAndUsage": "SODIUM SULFACETAMIDE 8% - SULFUR 4% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram of sodium sulfacetamide 8% and sulfur 4% cleanser contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a cleanser containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Green Tea Extract, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is."
},
{
"NDCCode": "58411-288-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (58411-288-10) > 4 g in 1 BOTTLE",
"NDC11Code": "58411-0288-10",
"ProductNDC": "58411-288",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Uv Protective Lip Treatment",
"NonProprietaryName": "Avobenzone, Octinoxate, Octocrylene, And Oxybenzone",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "100; 196; 120; 80",
"StrengthUnit": "mg/4g; mg/4g; mg/4g; mg/4g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "58411-353-40",
"PackageDescription": "1 TUBE in 1 CARTON (58411-353-40) > 5 g in 1 TUBE",
"NDC11Code": "58411-0353-40",
"ProductNDC": "58411-353",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Concealer",
"ProprietaryNameSuffix": "Ivory",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/5g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58411-254-80</NDCCode>
<PackageDescription>2 mL in 1 POUCH (58411-254-80) </PackageDescription>
<NDC11Code>58411-0254-80</NDC11Code>
<ProductNDC>58411-254</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Ultimate Sun Protection</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>4255; 1725; 805; 9430</StrengthNumber>
<StrengthUnit>mg/50mL; mg/50mL; mg/50mL; mg/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58411-254-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-254-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0254-60</NDC11Code>
<ProductNDC>58411-254</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Ultimate Sun Protection</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>4255; 1725; 805; 9430</StrengthNumber>
<StrengthUnit>mg/50mL; mg/50mL; mg/50mL; mg/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-254-61</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-254-61) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0254-61</NDC11Code>
<ProductNDC>58411-254</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Ultimate Sun Protection</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>4255; 1725; 805; 9430</StrengthNumber>
<StrengthUnit>mg/50mL; mg/50mL; mg/50mL; mg/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-254-62</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-254-62) > 15 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0254-62</NDC11Code>
<ProductNDC>58411-254</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Ultimate Sun Protection</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>4255; 1725; 805; 9430</StrengthNumber>
<StrengthUnit>mg/50mL; mg/50mL; mg/50mL; mg/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-142-80</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (58411-142-80) > 132.6 g in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>58411-0142-80</NDC11Code>
<ProductNDC>58411-142</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Ultimate Sun Protection</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3.98; 19.89; 6.63; 3.32; 6.63</StrengthNumber>
<StrengthUnit>mg/132.6g; mg/132.6g; mg/132.6g; mg/132.6g; mg/132.6g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-253-80</NDCCode>
<PackageDescription>2 mL in 1 POUCH (58411-253-80) </PackageDescription>
<NDC11Code>58411-0253-80</NDC11Code>
<ProductNDC>58411-253</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Ultimate Sun Protection</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>8406; 3408; 1590; 18630</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58411-345-61</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (58411-345-61) > 1.65 g in 1 POUCH (58411-345-80) </PackageDescription>
<NDC11Code>58411-0345-61</NDC11Code>
<ProductNDC>58411-345</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Sun Protection Eye</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>479; 495; 1749</StrengthNumber>
<StrengthUnit>mg/16.5g; mg/16.5g; mg/16.5g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-346-80</NDCCode>
<PackageDescription>2.12 g in 1 POUCH (58411-346-80) </PackageDescription>
<NDC11Code>58411-0346-80</NDC11Code>
<ProductNDC>58411-346</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Urban Environment</ProprietaryName>
<ProprietaryNameSuffix>Oil-free Uv Protector</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octocrylene, And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICA INC.</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1557; 953; 3971</StrengthNumber>
<StrengthUnit>mg/31.77g; mg/31.77g; mg/31.77g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-347-80</NDCCode>
<PackageDescription>2.18 g in 1 POUCH (58411-347-80) </PackageDescription>
<NDC11Code>58411-0347-80</NDC11Code>
<ProductNDC>58411-347</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Urban Environment Uv Protection</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1583; 1638; 5788</StrengthNumber>
<StrengthUnit>mg/54.6g; mg/54.6g; mg/54.6g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24470-951-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (24470-951-16) </PackageDescription>
<NDC11Code>24470-0951-16</NDC11Code>
<ProductNDC>24470-951</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide, Sulfur</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cintex Services, LLC</LabelerName>
<SubstanceName>SULFUR; SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>40; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each mL contains 80 mg of sodium sulfacetamide and 40 mg of colloidal sulfur in a vehicle consisting of: aloe vera gel, benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>25021-254-08</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (25021-254-08) / 8 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0254-08</NDC11Code>
<ProductNDC>25021-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213510</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5) .</IndicationAndUsage>
<Description>Docetaxel, USP is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula:. Docetaxel is a white to almost-white, crystalline powder with an empirical formula of C43H53NO14 and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg per mL concentration. Each mL contains 10 mg docetaxel (anhydrous) USP, 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid, USP 23% v/v, dehydrated alcohol, USP and polyethylene glycol 300 NF. Docetaxel Injection is available in multi-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>25021-254-16</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (25021-254-16) / 16 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0254-16</NDC11Code>
<ProductNDC>25021-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213510</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5) .</IndicationAndUsage>
<Description>Docetaxel, USP is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula:. Docetaxel is a white to almost-white, crystalline powder with an empirical formula of C43H53NO14 and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg per mL concentration. Each mL contains 10 mg docetaxel (anhydrous) USP, 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid, USP 23% v/v, dehydrated alcohol, USP and polyethylene glycol 300 NF. Docetaxel Injection is available in multi-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>27241-254-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (27241-254-01) </PackageDescription>
<NDC11Code>27241-0254-01</NDC11Code>
<ProductNDC>27241-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217410</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluphenazine hydrochloride tablets, USP are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride USP has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine hydrochloride USP is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Fluphenazine hydrochloride is described chemically as 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl]propyl]-1-piperazineethanol dihydrochloride and its molecular formula is C22H26F3N3OS.2HCl. The molecular structure is shown below. Fluphenazine Hydrochloride Tablets, USP contain 1 mg, 2.5 mg, 5 mg and 10 mg fluphenazine hydrochloride USP per tablet. Inactive ingredients: Aluminum Lake of the colorant FD&C yellow #6 for 2.5 mg, 5 mg and 10 mg only, microcrystalline cellulose, pregelatinized starch, magnesium stearate, lactose monohydrate, hypromellose, polyethylene glycol, polysorbate 80, polydextrose, triacetin, sodium alginate, lecithin (soy), and titanium dioxide. FDA approved dissolution acceptance criterion differ from the USP dissolution test 1.</Description>
</NDC>
<NDC>
<NDCCode>44523-624-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (44523-624-16) </PackageDescription>
<NDC11Code>44523-0624-16</NDC11Code>
<ProductNDC>44523-624</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250127</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BioComp Pharma, Inc.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>80; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each mL contains 80 mg of sodium sulfacetamide and 40 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, polyethylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>52187-531-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (52187-531-16) </PackageDescription>
<NDC11Code>52187-0531-16</NDC11Code>
<ProductNDC>52187-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide, Sulfur</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200520</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>KMM Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFUR; SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>40; 80</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each mL contains 80 mg of sodium sulfacetamide and 40 mg of colloidal sulfur in a vehicle consisting of: aloe vera gel, benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>55111-254-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (55111-254-01) </PackageDescription>
<NDC11Code>55111-0254-01</NDC11Code>
<ProductNDC>55111-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076649</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-254-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-254-05) </PackageDescription>
<NDC11Code>55111-0254-05</NDC11Code>
<ProductNDC>55111-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076649</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-254-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (55111-254-10) </PackageDescription>
<NDC11Code>55111-0254-10</NDC11Code>
<ProductNDC>55111-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076649</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-254-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (55111-254-30) </PackageDescription>
<NDC11Code>55111-0254-30</NDC11Code>
<ProductNDC>55111-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076649</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-254-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-254-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-254-79) </PackageDescription>
<NDC11Code>55111-0254-78</NDC11Code>
<ProductNDC>55111-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076649</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol USP is a racemic mixture with the following structure:. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide. Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1) and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Carvedilol Tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>58657-469-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (58657-469-16) </PackageDescription>
<NDC11Code>58657-0469-16</NDC11Code>
<ProductNDC>58657-469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 8% And Sulfur 4% Cleanser</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Method Pharmaceuticals</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>80; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SODIUM SULFACETAMIDE 8% - SULFUR 4% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram of sodium sulfacetamide 8% and sulfur 4% cleanser contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a cleanser containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Green Tea Extract, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>59572-711-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (59572-711-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>59572-0711-01</NDC11Code>
<ProductNDC>59572-711</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reblozyl</ProprietaryName>
<NonProprietaryName>Luspatercept</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191108</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761136</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>LUSPATERCEPT</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Erythroid Maturation Agent [EPC], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REBLOZYL is an erythroid maturation agent indicated for the treatment of: 1 Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions (1.1)., 2 Anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions (1.2)., 3 Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) (1.3)., 4 Limitations of Use: REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia (1.4).</IndicationAndUsage>
<Description>Luspatercept-aamt is an erythroid maturation agent. Luspatercept-aamt is a receptor fusion protein consisting of a modified extracellular domain of the human activin receptor type IIB linked to a human IgG1 Fc domain with a calculated molecular mass of approximately 76 kD. Luspatercept is produced in Chinese hamster ovary cells by recombinant DNA technology. REBLOZYL (luspatercept-aamt) for injection is a sterile, preservative-free, white to off-white, lyophilized powder in single-dose vials for subcutaneous use after reconstitution. Each 25 mg single-dose vial provides nominal 25 mg of luspatercept-aamt and citric acid monohydrate (0.085 mg), polysorbate 80 (0.10 mg), sucrose (45 mg), and tri-sodium citrate dihydrate (1.35 mg) at pH 6.5. After reconstitution with 0.68 mL Sterile Water for Injection USP, the resulting concentration is 25 mg/0.5 mL of luspatercept-aamt and the nominal deliverable volume is 0.5 mL. Each 75 mg single-dose vial provides nominal 75 mg of luspatercept-aamt and citric acid monohydrate (0.254 mg), polysorbate 80 (0.30 mg), sucrose (135 mg), and tri-sodium citrate dihydrate (4.06 mg) at pH 6.5. After reconstitution with 1.6 mL Sterile Water for Injection USP, the resulting concentration is 75 mg/1.5 mL (50 mg/mL) of luspatercept-aamt and the nominal deliverable volume is 1.5 mL.</Description>
</NDC>
<NDC>
<NDCCode>59572-775-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (59572-775-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>59572-0775-01</NDC11Code>
<ProductNDC>59572-775</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reblozyl</ProprietaryName>
<NonProprietaryName>Luspatercept</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191108</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761136</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>LUSPATERCEPT</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Erythroid Maturation Agent [EPC], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REBLOZYL is an erythroid maturation agent indicated for the treatment of: 1 Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions (1.1)., 2 Anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions (1.2)., 3 Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) (1.3)., 4 Limitations of Use: REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia (1.4).</IndicationAndUsage>
<Description>Luspatercept-aamt is an erythroid maturation agent. Luspatercept-aamt is a receptor fusion protein consisting of a modified extracellular domain of the human activin receptor type IIB linked to a human IgG1 Fc domain with a calculated molecular mass of approximately 76 kD. Luspatercept is produced in Chinese hamster ovary cells by recombinant DNA technology. REBLOZYL (luspatercept-aamt) for injection is a sterile, preservative-free, white to off-white, lyophilized powder in single-dose vials for subcutaneous use after reconstitution. Each 25 mg single-dose vial provides nominal 25 mg of luspatercept-aamt and citric acid monohydrate (0.085 mg), polysorbate 80 (0.10 mg), sucrose (45 mg), and tri-sodium citrate dihydrate (1.35 mg) at pH 6.5. After reconstitution with 0.68 mL Sterile Water for Injection USP, the resulting concentration is 25 mg/0.5 mL of luspatercept-aamt and the nominal deliverable volume is 0.5 mL. Each 75 mg single-dose vial provides nominal 75 mg of luspatercept-aamt and citric acid monohydrate (0.254 mg), polysorbate 80 (0.30 mg), sucrose (135 mg), and tri-sodium citrate dihydrate (4.06 mg) at pH 6.5. After reconstitution with 1.6 mL Sterile Water for Injection USP, the resulting concentration is 75 mg/1.5 mL (50 mg/mL) of luspatercept-aamt and the nominal deliverable volume is 1.5 mL.</Description>
</NDC>
<NDC>
<NDCCode>70529-254-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70529-254-01) * 1 TUBE in 1 CARTON (17478-840-05) > 5 mL in 1 TUBE * .55 mL in 1 POUCH (67777-121-13) </PackageDescription>
<NDC11Code>70529-0254-01</NDC11Code>
<ProductNDC>70529-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venipuncture Px1</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040433</ApplicationNumber>
<LabelerName>IT3 Medical LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lidocaine HCl 2% Jelly is a sterile, aqueous product that contains a local anesthetic agent and is administered topically. (See INDICATIONS for specific uses.). Lidocaine HCl 2% Jelly contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. Its molecular formula is C14H22N2O HCl and its molecular weight is 270.80. Lidocaine HCl 2% Jelly also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of Lidocaine HCl 2% Jelly 30 mL and 5 mL tubes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust pH between 6.0 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>71610-254-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-254-30) </PackageDescription>
<NDC11Code>71610-0254-30</NDC11Code>
<ProductNDC>71610-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204170</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2019-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate extended-release tablets, USP are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Zolpidem tartrate extended-release tablets, USP contain zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate extended-release tablets, USP are available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)tartrate (2:1). It has the following structure:. Zolpidem tartrate is a white to off-white crystalline powder that is slightly soluble in water, sparingly soluble in alcohol, and propylene glycol. It has a molecular weight of 764.86. Zolpidem tartrate extended-release tablets, USP consist of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide red, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80. The 12.5 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide yellow, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80.The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, and ammonium hydroxide.It meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72162-2247-2</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (72162-2247-2) </PackageDescription>
<NDC11Code>72162-2247-02</NDC11Code>
<ProductNDC>72162-2247</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 8% And Sulfur 4% Cleanser</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>80; 40</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SODIUM SULFACETAMIDE 8% - SULFUR 4% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram of sodium sulfacetamide 8% and sulfur 4% cleanser contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a cleanser containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Green Tea Extract, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>81672-5051-1</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (81672-5051-1) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>81672-5051-01</NDC11Code>
<ProductNDC>81672-5051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vtama</ProprietaryName>
<NonProprietaryName>Tapinarof</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215272</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>TAPINAROF</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Aryl Hydrocarbon Receptor Agonist [EPC], Aryl Hydrocarbon Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>VTAMA (tapinarof) cream contains tapinarof as the active ingredient. Tapinarof is an aryl hydrocarbon receptor agonist. Tapinarof is a white to pale brown powder. Chemically, tapinarof is 3, 5-dihydroxy-4-isopropyl-trans-stilbene, also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol, with the empirical formula C17H18O2, a molecular weight of 254.32, and the following structural formula. Each gram of VTAMA cream for topical use contains 10 mg of tapinarof in a white to off-white cream. VTAMA cream also contains the following inactive ingredients: benzoic acid, butylated hydroxytoluene, citric acid monohydrate, diethylene glycol monoethyl ether, edetate disodium, emulsifying wax, medium-chain triglycerides, polyoxyl 2 stearyl ether, polyoxyl 20 stearyl ether, polysorbate 80, propylene glycol, purified water, and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>82429-126-16</NDCCode>
<PackageDescription>454 g in 1 BOTTLE, PLASTIC (82429-126-16) </PackageDescription>
<NDC11Code>82429-0126-16</NDC11Code>
<ProductNDC>82429-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 8% And Sulfur 4% Cleanser</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Gabar Health Sciences Corp.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>80; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SODIUM SULFACETAMIDE 8% - SULFUR 4% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram of sodium sulfacetamide 8% and sulfur 4% cleanser contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a cleanser containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Green Tea Extract, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>58411-288-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58411-288-10) > 4 g in 1 BOTTLE</PackageDescription>
<NDC11Code>58411-0288-10</NDC11Code>
<ProductNDC>58411-288</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Uv Protective Lip Treatment</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>100; 196; 120; 80</StrengthNumber>
<StrengthUnit>mg/4g; mg/4g; mg/4g; mg/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-353-40</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-353-40) > 5 g in 1 TUBE</PackageDescription>
<NDC11Code>58411-0353-40</NDC11Code>
<ProductNDC>58411-353</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Concealer</ProprietaryName>
<ProprietaryNameSuffix>Ivory</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/5g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
</NDCList>