{
"NDC": [
{
"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": "0703-3216-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-3216-01) / 16.7 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00703-3216-01",
"ProductNDC": "0703-3216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200325",
"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": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200325",
"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), 150 mg (25 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": "0703-1153-83",
"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": "0703-3218-81",
"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": "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": "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": "0363-3216-01",
"PackageDescription": "14.2 g in 1 BOTTLE (0363-3216-01) ",
"NDC11Code": "00363-3216-01",
"ProductNDC": "0363-3216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Spf 60 Sunscreen",
"NonProprietaryName": "Titanium Dioxide - 6.00% Zinc Oxide - 4.70%",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130213",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Walgreens",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "6; 4.7",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130213",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "0591-3216-30",
"PackageDescription": "30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17) ",
"NDC11Code": "00591-3216-30",
"ProductNDC": "0591-3216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone",
"NonProprietaryName": "Testosterone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076737",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151204",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.",
"Description": "Testosterone gel 1% for topical use is a clear, colorless hydroalcoholic gel containing testosterone, USP. The active pharmacologic ingredient in testosterone gel 1% is testosterone, USP, an androgen. Testosterone, USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. Pharmacologically inactive ingredients in testosterone gel 1% are carbomer homopolymer type C, ethyl alcohol 68.9%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active."
},
{
"NDCCode": "11054-001-12",
"PackageDescription": "3216 L in 1 CYLINDER (11054-001-12) ",
"NDC11Code": "11054-0001-12",
"ProductNDC": "11054-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Air",
"NonProprietaryName": "Air",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206023",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "210",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "19971106",
"SamplePackage": "N"
},
{
"NDCCode": "11054-110-12",
"PackageDescription": "3216 L in 1 CYLINDER (11054-110-12) ",
"NDC11Code": "11054-0110-12",
"ProductNDC": "11054-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Air",
"NonProprietaryName": "Air",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205845",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "210",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971106",
"SamplePackage": "N"
},
{
"NDCCode": "36987-3216-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-3216-1)",
"NDC11Code": "36987-3216-01",
"ProductNDC": "36987-3216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Western Water Hemp",
"NonProprietaryName": "Western Water Hemp",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AMARANTHUS TUBERCULATUS POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-3216-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-3216-2)",
"NDC11Code": "36987-3216-02",
"ProductNDC": "36987-3216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Western Water Hemp",
"NonProprietaryName": "Western Water Hemp",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AMARANTHUS TUBERCULATUS POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-3216-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-3216-3)",
"NDC11Code": "36987-3216-03",
"ProductNDC": "36987-3216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Western Water Hemp",
"NonProprietaryName": "Western Water Hemp",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AMARANTHUS TUBERCULATUS POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-3216-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-3216-4)",
"NDC11Code": "36987-3216-04",
"ProductNDC": "36987-3216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Western Water Hemp",
"NonProprietaryName": "Western Water Hemp",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AMARANTHUS TUBERCULATUS POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-3216-1",
"PackageDescription": "80 PELLET in 1 VIAL, GLASS (37662-3216-1) ",
"NDC11Code": "37662-3216-01",
"ProductNDC": "37662-3216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neodymium Oxydatum",
"NonProprietaryName": "Neodymium Oxydatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230522",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "NEODYMIUM OXIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230522",
"SamplePackage": "N"
},
{
"NDCCode": "37662-3216-2",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-3216-2) ",
"NDC11Code": "37662-3216-02",
"ProductNDC": "37662-3216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neodymium Oxydatum",
"NonProprietaryName": "Neodymium Oxydatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230522",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "NEODYMIUM OXIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230522",
"SamplePackage": "N"
},
{
"NDCCode": "37662-3216-3",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-3216-3) ",
"NDC11Code": "37662-3216-03",
"ProductNDC": "37662-3216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neodymium Oxydatum",
"NonProprietaryName": "Neodymium Oxydatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230522",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "NEODYMIUM OXIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230522",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>0703-3216-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-3216-01) / 16.7 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-3216-01</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>20200325</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>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200325</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), 150 mg (25 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>0703-1153-83</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>0703-3218-81</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>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>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>0363-3216-01</NDCCode>
<PackageDescription>14.2 g in 1 BOTTLE (0363-3216-01) </PackageDescription>
<NDC11Code>00363-3216-01</NDC11Code>
<ProductNDC>0363-3216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Spf 60 Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide - 6.00% Zinc Oxide - 4.70%</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6; 4.7</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0591-3216-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17) </PackageDescription>
<NDC11Code>00591-3216-30</NDC11Code>
<ProductNDC>0591-3216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076737</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.</IndicationAndUsage>
<Description>Testosterone gel 1% for topical use is a clear, colorless hydroalcoholic gel containing testosterone, USP. The active pharmacologic ingredient in testosterone gel 1% is testosterone, USP, an androgen. Testosterone, USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. Pharmacologically inactive ingredients in testosterone gel 1% are carbomer homopolymer type C, ethyl alcohol 68.9%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.</Description>
</NDC>
<NDC>
<NDCCode>11054-001-12</NDCCode>
<PackageDescription>3216 L in 1 CYLINDER (11054-001-12) </PackageDescription>
<NDC11Code>11054-0001-12</NDC11Code>
<ProductNDC>11054-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206023</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11054-110-12</NDCCode>
<PackageDescription>3216 L in 1 CYLINDER (11054-110-12) </PackageDescription>
<NDC11Code>11054-0110-12</NDC11Code>
<ProductNDC>11054-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205845</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36987-3216-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-3216-1)</PackageDescription>
<NDC11Code>36987-3216-01</NDC11Code>
<ProductNDC>36987-3216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Western Water Hemp</ProprietaryName>
<NonProprietaryName>Western Water Hemp</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AMARANTHUS TUBERCULATUS POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-3216-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-3216-2)</PackageDescription>
<NDC11Code>36987-3216-02</NDC11Code>
<ProductNDC>36987-3216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Western Water Hemp</ProprietaryName>
<NonProprietaryName>Western Water Hemp</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AMARANTHUS TUBERCULATUS POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-3216-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-3216-3)</PackageDescription>
<NDC11Code>36987-3216-03</NDC11Code>
<ProductNDC>36987-3216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Western Water Hemp</ProprietaryName>
<NonProprietaryName>Western Water Hemp</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AMARANTHUS TUBERCULATUS POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-3216-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-3216-4)</PackageDescription>
<NDC11Code>36987-3216-04</NDC11Code>
<ProductNDC>36987-3216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Western Water Hemp</ProprietaryName>
<NonProprietaryName>Western Water Hemp</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AMARANTHUS TUBERCULATUS POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-3216-1</NDCCode>
<PackageDescription>80 PELLET in 1 VIAL, GLASS (37662-3216-1) </PackageDescription>
<NDC11Code>37662-3216-01</NDC11Code>
<ProductNDC>37662-3216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neodymium Oxydatum</ProprietaryName>
<NonProprietaryName>Neodymium Oxydatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230522</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>NEODYMIUM OXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-3216-2</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-3216-2) </PackageDescription>
<NDC11Code>37662-3216-02</NDC11Code>
<ProductNDC>37662-3216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neodymium Oxydatum</ProprietaryName>
<NonProprietaryName>Neodymium Oxydatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230522</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>NEODYMIUM OXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-3216-3</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-3216-3) </PackageDescription>
<NDC11Code>37662-3216-03</NDC11Code>
<ProductNDC>37662-3216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neodymium Oxydatum</ProprietaryName>
<NonProprietaryName>Neodymium Oxydatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230522</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>NEODYMIUM OXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>