{
"NDC": [
{
"NDCCode": "0703-9526-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-9526-81",
"ProductNDC": "0703-9526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073303",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "80; 16",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240815",
"SamplePackage": "N",
"Description": "Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28."
},
{
"NDCCode": "0703-9526-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-9526-01",
"ProductNDC": "0703-9526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19911101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073303",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "80; 16",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19911101",
"SamplePackage": "N",
"IndicationAndUsage": "Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).",
"Description": "Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28."
},
{
"NDCCode": "0703-1153-83",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0703-1153-83) / 4 mL in 1 VIAL, SINGLE-USE (0703-1153-81) ",
"NDC11Code": "00703-1153-83",
"ProductNDC": "0703-1153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norepinephrine Bitartrate",
"NonProprietaryName": "Norepinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040455",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N"
},
{
"NDCCode": "0703-3213-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-81) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-3213-81",
"ProductNDC": "0703-3213",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200707",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "0703-3216-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-3216-81) / 16.7 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-3216-81",
"ProductNDC": "0703-3216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200305",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "0703-3218-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-3218-81) / 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-3218-81",
"ProductNDC": "0703-3218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200305",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "0703-3678-81",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-81) > 40 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00703-3678-81",
"ProductNDC": "0703-3678",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"StartMarketingDate": "20151214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040843",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151214",
"SamplePackage": "N",
"IndicationAndUsage": "Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the:Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as single-agent (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen (1.7) Treatment of adults with rheumatoid arthritis (RA). (1.8)Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9)Treatment of adults with severe psoriasis. (1.10).",
"Description": "Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.45. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5."
},
{
"NDCCode": "0703-4239-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-4239-81) > 60 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-4239-81",
"ProductNDC": "0703-4239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077269",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Active",
"LastUpdate": "2022-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160119",
"SamplePackage": "N",
"IndicationAndUsage": "Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.",
"Description": "Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "0703-4244-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-4244-81) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-4244-81",
"ProductNDC": "0703-4244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077269",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Active",
"LastUpdate": "2022-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160115",
"SamplePackage": "N",
"IndicationAndUsage": "Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.",
"Description": "Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "0703-4246-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-4246-81) > 15 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-4246-81",
"ProductNDC": "0703-4246",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077269",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Active",
"LastUpdate": "2022-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151125",
"SamplePackage": "N",
"IndicationAndUsage": "Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.",
"Description": "Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "0703-4248-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-81) > 45 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-4248-81",
"ProductNDC": "0703-4248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077269",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Active",
"LastUpdate": "2022-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151209",
"SamplePackage": "N",
"IndicationAndUsage": "Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.",
"Description": "Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "0703-4432-81",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0703-4432-81) > 2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00703-4432-81",
"ProductNDC": "0703-4432",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irinotecan Hydrochloride",
"NonProprietaryName": "Irinotecan Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150701",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090101",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "IRINOTECAN HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150701",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "0703-4434-81",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0703-4434-81) > 5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00703-4434-81",
"ProductNDC": "0703-4434",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irinotecan Hydrochloride",
"NonProprietaryName": "Irinotecan Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150701",
"EndMarketingDate": "20190630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090101",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "IRINOTECAN HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150701",
"EndMarketingDatePackage": "20190630",
"SamplePackage": "N"
},
{
"NDCCode": "0703-4502-84",
"PackageDescription": "25 VIAL, SINGLE-USE in 1 TRAY (0703-4502-84) > 2 mL in 1 VIAL, SINGLE-USE (0703-4502-81) ",
"NDC11Code": "00703-4502-84",
"ProductNDC": "0703-4502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20150817",
"EndMarketingDate": "20210331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073135",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150817",
"EndMarketingDatePackage": "20210331",
"SamplePackage": "N"
},
{
"NDCCode": "0703-4764-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-4764-81) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-4764-81",
"ProductNDC": "0703-4764",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160303",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection is indicated in combination with cisplatin. Paclitaxel Injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a natural product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "0703-4766-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-4766-81) > 16.7 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-4766-81",
"ProductNDC": "0703-4766",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160303",
"EndMarketingDate": "20190831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160303",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "0703-4768-81",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-4768-81) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-4768-81",
"ProductNDC": "0703-4768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075184",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160303",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection is indicated in combination with cisplatin. Paclitaxel Injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a natural product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C."
},
{
"NDCCode": "0703-9514-83",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) ",
"NDC11Code": "00703-9514-83",
"ProductNDC": "0703-9514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073303",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "80; 16",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240711",
"SamplePackage": "N",
"Description": "Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28."
},
{
"NDCCode": "55946-703-53",
"PackageDescription": "81 g in 1 TUBE (55946-703-53) ",
"NDC11Code": "55946-0703-53",
"ProductNDC": "55946-703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calendula Diaper Rash",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Weleda, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "12",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "0143-9526-10",
"PackageDescription": "10 POUCH in 1 CASE (0143-9526-10) / 1 BAG in 1 POUCH / 50 mL in 1 BAG",
"NDC11Code": "00143-9526-10",
"ProductNDC": "0143-9526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206407",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200130",
"SamplePackage": "N",
"Description": "Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 4-[(S)-α, 2, 3-trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the molecular formula is C13H16N2 HCl and the structural formula is:. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "15455-9526-1",
"PackageDescription": "453.6 g in 1 JAR (15455-9526-1)",
"NDC11Code": "15455-9526-01",
"ProductNDC": "15455-9526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cidaleaze",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150811",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alvix Laboratories, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-08-29"
},
{
"NDCCode": "61589-9526-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (61589-9526-1) / 30 g in 1 BOTTLE",
"NDC11Code": "61589-9526-01",
"ProductNDC": "61589-9526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Restore And Renew Multi Action Serum Foundation Sunscreen Broad Spectrum Spf 20 Calico",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BCM Cosmetique SAS",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "2.1; .51",
"StrengthUnit": "g/30g; g/30g",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Directions for suncreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.",
"Description": "No7. Restore & Renew. MULTI ACTION. Serum Foundation. Visibly conceals the 5 key signs of ageing. LIGHT - MEDIUM COVERAGE. 30 ml e 1 US Fl. Oz. Tackle the advanced signs of aging with our multi-tasking, age-defying foundation. Enriched with No7 Restore & Renew MULTI ACTION technology: MATRIXYL 3000 PLUS and Firming & Brightening Complexes, it visibly improves the 5 key signs of aging by instantly concealing fine lines & wrinkles, age spots, uneven texture & tone, with skin appearing lifted and firmer over time*. A light - medium, buildable coverage that gently glides on and blends seamlessly. The Flexible Formula moves in harmony with your facial expressions throughout the day, ensuring the foundation doesn't migrate into lnes or wrinkles. SPF 20 helps to actively protect skin from the damaging effects of the sun. For best results blend on smoothyl and evenly with your fingers, sponge or brush. Use on top of your regular Restore & Renew regime to superchage your results. Suitable for sensitive skin. *whilst wearing foundation."
},
{
"NDCCode": "68788-9526-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68788-9526-3) ",
"NDC11Code": "68788-9526-03",
"ProductNDC": "68788-9526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079132",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140120",
"SamplePackage": "N"
},
{
"NDCCode": "68788-9526-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (68788-9526-6) ",
"NDC11Code": "68788-9526-06",
"ProductNDC": "68788-9526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079132",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140120",
"SamplePackage": "N"
},
{
"NDCCode": "0113-0703-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (0113-0703-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "00113-0703-26",
"ProductNDC": "0113-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Tussin Cf",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140729",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "20; 200; 10",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140729",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:. nasal congestion. cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "0113-0703-34",
"PackageDescription": "1 BOTTLE in 1 CARTON (0113-0703-34) > 237 mL in 1 BOTTLE",
"NDC11Code": "00113-0703-34",
"ProductNDC": "0113-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Tussin Cf",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140729",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "20; 200; 10",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140729",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:. nasal congestion. cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "0132-0703-36",
"PackageDescription": "37 mL in 1 BOTTLE, WITH APPLICATOR (0132-0703-36) ",
"NDC11Code": "00132-0703-36",
"ProductNDC": "0132-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fleet",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "20020510",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "C.B. Fleet Company, Inc.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "10",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020510",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of fecal impaction. for relief of occasional constipation. for removal of residue after barium administration."
},
{
"NDCCode": "0135-0703-01",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0703-01) / 96.4 g in 1 TUBE",
"NDC11Code": "00135-0703-01",
"ProductNDC": "0135-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne",
"ProprietaryNameSuffix": "Clinical White Enamel Strengthening",
"NonProprietaryName": "Potassium Nitrate, Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 2.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
},
{
"NDCCode": "0135-0703-02",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0703-02) / 62.5 g in 1 TUBE",
"NDC11Code": "00135-0703-02",
"ProductNDC": "0135-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne",
"ProprietaryNameSuffix": "Clinical White Enamel Strengthening",
"NonProprietaryName": "Potassium Nitrate, Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 2.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
},
{
"NDCCode": "0135-0703-05",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0703-05) / 156 g in 1 TUBE",
"NDC11Code": "00135-0703-05",
"ProductNDC": "0135-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne",
"ProprietaryNameSuffix": "Clinical White Enamel Strengthening",
"NonProprietaryName": "Potassium Nitrate, Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 2.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0703-9526-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-9526-81</NDC11Code>
<ProductNDC>0703-9526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073303</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28.</Description>
</NDC>
<NDC>
<NDCCode>0703-9526-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-9526-01</NDC11Code>
<ProductNDC>0703-9526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073303</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).</IndicationAndUsage>
<Description>Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28.</Description>
</NDC>
<NDC>
<NDCCode>0703-1153-83</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0703-1153-83) / 4 mL in 1 VIAL, SINGLE-USE (0703-1153-81) </PackageDescription>
<NDC11Code>00703-1153-83</NDC11Code>
<ProductNDC>0703-1153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norepinephrine Bitartrate</ProprietaryName>
<NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040455</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0703-3213-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-81) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-3213-81</NDC11Code>
<ProductNDC>0703-3213</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>0703-3216-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-3216-81) / 16.7 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-3216-81</NDC11Code>
<ProductNDC>0703-3216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>0703-3218-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-3218-81) / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-3218-81</NDC11Code>
<ProductNDC>0703-3218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>0703-3678-81</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-81) > 40 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00703-3678-81</NDC11Code>
<ProductNDC>0703-3678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methotrexate</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20151214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040843</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the:Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as single-agent (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen (1.7) Treatment of adults with rheumatoid arthritis (RA). (1.8)Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9)Treatment of adults with severe psoriasis. (1.10).</IndicationAndUsage>
<Description>Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.45. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>0703-4239-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-4239-81) > 60 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-4239-81</NDC11Code>
<ProductNDC>0703-4239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077269</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.</IndicationAndUsage>
<Description>Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>0703-4244-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-4244-81) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-4244-81</NDC11Code>
<ProductNDC>0703-4244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077269</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.</IndicationAndUsage>
<Description>Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>0703-4246-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-4246-81) > 15 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-4246-81</NDC11Code>
<ProductNDC>0703-4246</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077269</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.</IndicationAndUsage>
<Description>Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>0703-4248-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-81) > 45 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-4248-81</NDC11Code>
<ProductNDC>0703-4248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077269</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.</IndicationAndUsage>
<Description>Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0']-, (SP-4-2), and carboplatin, USP has the following structural formula. C6H12N2O4Pt M.W. 371.25. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5.0 to 7.0. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>0703-4432-81</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0703-4432-81) > 2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00703-4432-81</NDC11Code>
<ProductNDC>0703-4432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irinotecan Hydrochloride</ProprietaryName>
<NonProprietaryName>Irinotecan Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090101</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0703-4434-81</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0703-4434-81) > 5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00703-4434-81</NDC11Code>
<ProductNDC>0703-4434</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irinotecan Hydrochloride</ProprietaryName>
<NonProprietaryName>Irinotecan Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<EndMarketingDate>20190630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090101</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<EndMarketingDatePackage>20190630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0703-4502-84</NDCCode>
<PackageDescription>25 VIAL, SINGLE-USE in 1 TRAY (0703-4502-84) > 2 mL in 1 VIAL, SINGLE-USE (0703-4502-81) </PackageDescription>
<NDC11Code>00703-4502-84</NDC11Code>
<ProductNDC>0703-4502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20150817</StartMarketingDate>
<EndMarketingDate>20210331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073135</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150817</StartMarketingDatePackage>
<EndMarketingDatePackage>20210331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0703-4764-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-4764-81) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-4764-81</NDC11Code>
<ProductNDC>0703-4764</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection is indicated in combination with cisplatin. Paclitaxel Injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a natural product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>0703-4766-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-4766-81) > 16.7 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-4766-81</NDC11Code>
<ProductNDC>0703-4766</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160303</StartMarketingDate>
<EndMarketingDate>20190831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160303</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0703-4768-81</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-4768-81) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-4768-81</NDC11Code>
<ProductNDC>0703-4768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075184</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection is indicated in combination with cisplatin. Paclitaxel Injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a natural product with antitumor activity. Paclitaxel, USP is obtained from Taxus species. The chemical name for paclitaxel, USP is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel, USP has the following structural formula. C47H51NO14 M.W. 853.9. C47H51NO14 M.W. 853.9. Paclitaxel, USP is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C.</Description>
</NDC>
<NDC>
<NDCCode>0703-9514-83</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) </PackageDescription>
<NDC11Code>00703-9514-83</NDC11Code>
<ProductNDC>0703-9514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073303</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28.</Description>
</NDC>
<NDC>
<NDCCode>55946-703-53</NDCCode>
<PackageDescription>81 g in 1 TUBE (55946-703-53) </PackageDescription>
<NDC11Code>55946-0703-53</NDC11Code>
<ProductNDC>55946-703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calendula Diaper Rash</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Weleda, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0143-9526-10</NDCCode>
<PackageDescription>10 POUCH in 1 CASE (0143-9526-10) / 1 BAG in 1 POUCH / 50 mL in 1 BAG</PackageDescription>
<NDC11Code>00143-9526-10</NDC11Code>
<ProductNDC>0143-9526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206407</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 4-[(S)-α, 2, 3-trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the molecular formula is C13H16N2 HCl and the structural formula is:. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
</NDC>
<NDC>
<NDCCode>15455-9526-1</NDCCode>
<PackageDescription>453.6 g in 1 JAR (15455-9526-1)</PackageDescription>
<NDC11Code>15455-9526-01</NDC11Code>
<ProductNDC>15455-9526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cidaleaze</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150811</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alvix Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>61589-9526-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (61589-9526-1) / 30 g in 1 BOTTLE</PackageDescription>
<NDC11Code>61589-9526-01</NDC11Code>
<ProductNDC>61589-9526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Restore And Renew Multi Action Serum Foundation Sunscreen Broad Spectrum Spf 20 Calico</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BCM Cosmetique SAS</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2.1; .51</StrengthNumber>
<StrengthUnit>g/30g; g/30g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions for suncreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
<Description>No7. Restore & Renew. MULTI ACTION. Serum Foundation. Visibly conceals the 5 key signs of ageing. LIGHT - MEDIUM COVERAGE. 30 ml e 1 US Fl. Oz. Tackle the advanced signs of aging with our multi-tasking, age-defying foundation. Enriched with No7 Restore & Renew MULTI ACTION technology: MATRIXYL 3000 PLUS and Firming & Brightening Complexes, it visibly improves the 5 key signs of aging by instantly concealing fine lines & wrinkles, age spots, uneven texture & tone, with skin appearing lifted and firmer over time*. A light - medium, buildable coverage that gently glides on and blends seamlessly. The Flexible Formula moves in harmony with your facial expressions throughout the day, ensuring the foundation doesn't migrate into lnes or wrinkles. SPF 20 helps to actively protect skin from the damaging effects of the sun. For best results blend on smoothyl and evenly with your fingers, sponge or brush. Use on top of your regular Restore & Renew regime to superchage your results. Suitable for sensitive skin. *whilst wearing foundation.</Description>
</NDC>
<NDC>
<NDCCode>68788-9526-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68788-9526-3) </PackageDescription>
<NDC11Code>68788-9526-03</NDC11Code>
<ProductNDC>68788-9526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079132</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-9526-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68788-9526-6) </PackageDescription>
<NDC11Code>68788-9526-06</NDC11Code>
<ProductNDC>68788-9526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079132</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0113-0703-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0113-0703-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00113-0703-26</NDC11Code>
<ProductNDC>0113-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Tussin Cf</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140729</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 200; 10</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140729</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:. nasal congestion. cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0113-0703-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0113-0703-34) > 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00113-0703-34</NDC11Code>
<ProductNDC>0113-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Tussin Cf</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140729</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 200; 10</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:. nasal congestion. cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0132-0703-36</NDCCode>
<PackageDescription>37 mL in 1 BOTTLE, WITH APPLICATOR (0132-0703-36) </PackageDescription>
<NDC11Code>00132-0703-36</NDC11Code>
<ProductNDC>0132-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fleet</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20020510</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>C.B. Fleet Company, Inc.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of fecal impaction. for relief of occasional constipation. for removal of residue after barium administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0703-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0703-01) / 96.4 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0703-01</NDC11Code>
<ProductNDC>0135-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensodyne</ProprietaryName>
<ProprietaryNameSuffix>Clinical White Enamel Strengthening</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate, Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0703-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0703-02) / 62.5 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0703-02</NDC11Code>
<ProductNDC>0135-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensodyne</ProprietaryName>
<ProprietaryNameSuffix>Clinical White Enamel Strengthening</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate, Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0703-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0703-05) / 156 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0703-05</NDC11Code>
<ProductNDC>0135-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensodyne</ProprietaryName>
<ProprietaryNameSuffix>Clinical White Enamel Strengthening</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate, Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
</NDCList>