{
"NDC": [
{
"NDCCode": "45802-807-98",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (45802-807-98) / 100 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "45802-0807-98",
"ProductNDC": "45802-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206441",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181206",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone topical spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.",
"Description": "Desoximetasone Topical Spray, 0.25% for dermatologic use contains desoximetasone as the active ingredient. Desoximetasone is a corticosteroid with the chemical name of pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-, (11ß,16α)-. Desoximetasone has the molecular formula of C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is. Each gram of desoximetasone topical spray contains 2.5 mg of desoximetasone in a clear, colorless liquid with the following inactive ingredients: glyceryl oleate, isopropyl alcohol (23.4%), isopropyl myristate, L-menthol, and mineral oil. Desoximetasone topical spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients."
},
{
"NDCCode": "45802-493-98",
"PackageDescription": "140 g in 1 TUBE (45802-493-98) ",
"NDC11Code": "45802-0493-98",
"ProductNDC": "45802-493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ammonium Lactate",
"NonProprietaryName": "Ammonium Lactate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075774",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "AMMONIUM LACTATE",
"StrengthNumber": "12",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Acidifying Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20060816",
"SamplePackage": "N",
"IndicationAndUsage": "Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.",
"Description": "*Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula."
},
{
"NDCCode": "84845-807-02",
"PackageDescription": "1 CARTON in 1 CARTON (84845-807-02) / 10 BAG in 1 CARTON / 1000 mL in 1 BAG (84845-807-01) ",
"NDC11Code": "84845-0807-02",
"ProductNDC": "84845-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride And Water Solution",
"NonProprietaryName": "Sodium Chloride, Water",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241202",
"EndMarketingDate": "20341201",
"MarketingCategoryName": "EMERGENCY USE AUTHORIZATION",
"LabelerName": "Global Guard Services LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "g/9mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241202",
"EndMarketingDatePackage": "20341201",
"SamplePackage": "N",
"IndicationAndUsage": "This product is an isotonic sterilizing aqueous solution of sodium chloride. Chemical Name: Sodium chloride Molecular Formula: NaCl Molecular Weight: 58.44 Osmolality: 260~320 mOsmol/kg. [Character] This product is colorless and clear liquid. [Indications] It is used to regulate the balance of water and electrolytes in the body. [Specification] 50ml: 0.45g; 100ml: 0.9g; 250ml: 2.25g; 500ml: 4.5g; 1000ml: 9g [Dosage and Usage] Intravenous infusion, dosage according to the need of the disease. [Adverse Reactions] Excessive and rapid infusion can cause water and sodium retention, edema, elevated blood pressure, rapid heart rate, chest tightness, dyspnea, and even acute left heart failure. [Precautions] (1) Use with caution in the following cases: ① Edematous diseases, such as nephrotic syndrome, cirrhosis ascites, congestive heart failure, acute left heart failure, brain edema and idiopathic edema; ② Acute renal failure oliguria stage, chronic renal failure urine volume decreased and poor response to diuretic drugs; ③ Hypertension; ④ Hypokalemia. (2) Follow-up examination: ① Serum sodium, potassium, chlorine concentration; ② Blood acid-base balance index; ③ Kidney function; ④ Blood pressure and cardiopulmonary function. [Medication in pregnant women and lactating women] Not clear. [Medication in children] The amount and speed of fluid supplementation should be strictly controlled. [Medication in the elderly] The amount and speed of fluid supplementation should be strictly controlled. [Drug interactions] Should not be used with drugs with known incompatibility contraindications. [Drug overdose] For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis. [Pharmacology and toxicology] Sodium and chlorine are important electrolytes in the body, mainly in the extracellular fluid, and play a very important role in maintaining the normal blood and extracellular fluid volume and osmotic pressure of the human body. The normal serum sodium concentration is 135~145mmol/L, accounting for 92% of the plasma cation and 90% of the total osmotic pressure, so the amount of plasma sodium plays a decisive role in the osmotic pressure. The normal serum chlorine concentration is 98~106mmol/L, which is mainly regulated by the human body through the hypothalamus, posterior pituitary and kidney to maintain the stability of body fluid volume and osmotic pressure. [Pharmacokinetics] In the gastrointestinal tract, sodium is absorbed almost entirely through the active transport of intestinal mucosal cells. Sodium is excreted primarily by the kidneys. [Storage] Sealed storage. [Package] 1. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve and double plug). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag. 2. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve double plug, double aseptic packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag. [Validity] (1) The product of 50ml,100ml and 1000ml specifications is valid for 24 months. (2) The validity period of 250ml,500ml is 36 months. [Executive standard] Pharmacopoeia of the People's Republic of China (2020, Volume II) [Approval Number] (1) GuoYaoZhunZi: H20033208 (50ml: 0.45g) (2) GuoYaoZhunZi: H20023682 (100ml: 0.9g) (3) GuoYaoZhunZi: H20023146 (250ml: 2.25g) (4) GuoYaoZhunZi: H20023145 (500ml: 4.5g) (5) GuoYaoZhunZi: H20023750 (1000ml: 9g) [Pharmaceutical marketing authorization holder] Name: Huaren Pharmaceutical Co., Ltd. Registered Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. [Manufacturer] Enterprise Name: Huaren Pharmaceutical Co., Ltd. Production Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. Zip code: 266101 Tel.: 400-0648885 0532-67709071 Fax: 0532-88702625 Website：http//www.qdhuaren.com."
},
{
"NDCCode": "0143-9204-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0143-9204-01) / 1 mL in 1 VIAL, GLASS",
"NDC11Code": "00143-9204-01",
"ProductNDC": "0143-9204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204490",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection, USP is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, anhydrous. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.9. It is highly lipophilic and practically insoluble in water."
},
{
"NDCCode": "0143-9205-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0143-9205-01) / 4 mL in 1 VIAL, GLASS",
"NDC11Code": "00143-9205-01",
"ProductNDC": "0143-9205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204490",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection, USP is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, anhydrous. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.9. It is highly lipophilic and practically insoluble in water."
},
{
"NDCCode": "0409-0016-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01) / 16 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0016-01",
"ProductNDC": "0409-0016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220110",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous) and multiple-dose vials containing 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0201-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0201-02) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0201-02",
"ProductNDC": "0409-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110317",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110317",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0201-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0201-10) / 8 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0201-10",
"ProductNDC": "0409-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110317",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110317",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0201-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0201-20) / 16 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0201-20",
"ProductNDC": "0409-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110317",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110317",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-1732-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-1732-01) / 16 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-1732-01",
"ProductNDC": "0409-1732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210628",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-2026-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2026-01) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-2026-01",
"ProductNDC": "0409-2026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220110",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous) and multiple-dose vials containing 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-7870-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-7870-01) / 8 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-7870-01",
"ProductNDC": "0409-7870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210628",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "10135-807-13",
"PackageDescription": "100 POUCH in 1 CARTON (10135-807-13) / 1.58 g in 1 POUCH (10135-807-11) ",
"NDC11Code": "10135-0807-13",
"ProductNDC": "10135-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride For Oral Solution",
"NonProprietaryName": "Potassium Chloride For Oral Solution",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212183",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/1.58g",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose."
},
{
"NDCCode": "10135-807-15",
"PackageDescription": "30 POUCH in 1 CARTON (10135-807-15) / 1.58 g in 1 POUCH (10135-807-11) ",
"NDC11Code": "10135-0807-15",
"ProductNDC": "10135-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride For Oral Solution",
"NonProprietaryName": "Potassium Chloride For Oral Solution",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212183",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/1.58g",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose."
},
{
"NDCCode": "10237-807-40",
"PackageDescription": "113 g in 1 CANISTER (10237-807-40) ",
"NDC11Code": "10237-0807-40",
"ProductNDC": "10237-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ultramax",
"ProprietaryNameSuffix": "Antiperspirant Deodorant Cool Blast",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031201",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20031201",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm perspiration."
},
{
"NDCCode": "11084-807-12",
"PackageDescription": "1200 mL in 1 BOTTLE, PLASTIC (11084-807-12) ",
"NDC11Code": "11084-0807-12",
"ProductNDC": "11084-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindest Kare Advanced Antimicrobial Foam Handwash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180401",
"SamplePackage": "N",
"IndicationAndUsage": "Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments."
},
{
"NDCCode": "11084-807-13",
"PackageDescription": "444 mL in 1 BOTTLE, PLASTIC (11084-807-13) ",
"NDC11Code": "11084-0807-13",
"ProductNDC": "11084-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindest Kare Advanced Antimicrobial Foam Handwash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments."
},
{
"NDCCode": "11084-807-27",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (11084-807-27) ",
"NDC11Code": "11084-0807-27",
"ProductNDC": "11084-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindest Kare Advanced Antimicrobial Foam Handwash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180401",
"SamplePackage": "N",
"IndicationAndUsage": "Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments."
},
{
"NDCCode": "11084-807-41",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (11084-807-41) ",
"NDC11Code": "11084-0807-41",
"ProductNDC": "11084-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindest Kare Advanced Antimicrobial Foam Handwash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments."
},
{
"NDCCode": "11084-807-66",
"PackageDescription": "1000 mL in 1 BOTTLE (11084-807-66) ",
"NDC11Code": "11084-0807-66",
"ProductNDC": "11084-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindest Kare Advanced Antimicrobial Foam Handwash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments."
},
{
"NDCCode": "11084-807-67",
"PackageDescription": "1 CARTRIDGE in 1 KIT (11084-807-67) / 1000 mL in 1 CARTRIDGE",
"NDC11Code": "11084-0807-67",
"ProductNDC": "11084-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindest Kare Advanced Antimicrobial Foam Handwash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments."
},
{
"NDCCode": "11084-807-68",
"PackageDescription": "2 CARTRIDGE in 1 BOX (11084-807-68) / 1000 mL in 1 CARTRIDGE",
"NDC11Code": "11084-0807-68",
"ProductNDC": "11084-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindest Kare Advanced Antimicrobial Foam Handwash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N",
"IndicationAndUsage": "Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments."
},
{
"NDCCode": "11673-807-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (11673-807-01) > 25 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE",
"NDC11Code": "11673-0807-01",
"ProductNDC": "11673-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Zinc Cold Remedy",
"NonProprietaryName": "Zincum Aceticum, Zincum Gluconicum",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20090612",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Target Corporation",
"SubstanceName": "ZINC ACETATE; ZINC GLUCONATE",
"StrengthNumber": "2; 1",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "13537-807-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-807-02) > 4 g in 1 TUBE (13537-807-01)",
"NDC11Code": "13537-0807-02",
"ProductNDC": "13537-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(fucsia Cautivante) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-807-01",
"PackageDescription": "1 BAG in 1 CYLINDER (14783-807-01) > 10050 mL in 1 BAG",
"NDC11Code": "14783-0807-01",
"ProductNDC": "14783-807",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Avobenzone, Ensulizole, Octocrylene, And Octisalate",
"DosageFormName": "LOTION",
"StartMarketingDate": "20150624",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Ventura International LTD",
"SubstanceName": "AVOBENZONE; ENSULIZOLE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": ".03; .025; .053; .05",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "15127-807-08",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (15127-807-08) ",
"NDC11Code": "15127-0807-08",
"ProductNDC": "15127-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen Extra Strength",
"ProprietaryNameSuffix": "Rapid Burst Cherry",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100908",
"EndMarketingDate": "20211230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Select Brand Dist.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100908",
"EndMarketingDatePackage": "20211230",
"SamplePackage": "N"
},
{
"NDCCode": "16714-807-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (16714-807-01) ",
"NDC11Code": "16714-0807-01",
"ProductNDC": "16714-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040480",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "5; 5; 5; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030909",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. In addition, each tablet for oral administration contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized corn starch. The 5 mg, 7.5 mg and 10 mg tablets contain D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake. The 12.5 mg, 15 mg, 20 mg, and 30 mg tablets contain D&C Yellow #10 Aluminum Lake."
},
{
"NDCCode": "16729-267-63",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE",
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"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula:. Docetaxel is a white to off-white powder with an empirical formula of C 43H 53NO 14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. One-vial Docetaxel Injection. Docetaxel Injection USP is a sterile, non-pyrogenic, pale-yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel anhydrous USP, in 4 mg anhydrous citric acid for pH adjustment, 520 mg polysorbate 80 and 395 mg dehydrated alcohol solution. Docetaxel Injection USP is available in multiple dose (20 mg/mL, 80 mg/4 mL and 160 mg/8 mL) vials containing 20 mg (1 mL), 80 mg (4 mL) or 160 mg (8 mL) docetaxel anhydrous USP. Docetaxel Injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution."
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<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, anhydrous. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.9. It is highly lipophilic and practically insoluble in water.</Description>
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<IndicationAndUsage>Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments.</IndicationAndUsage>
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<NDC>
<NDCCode>11084-807-13</NDCCode>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
<NDCCode>11084-807-27</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (11084-807-27) </PackageDescription>
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<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11084-807-41</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (11084-807-41) </PackageDescription>
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<ProductNDC>11084-807</ProductNDC>
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<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11084-807-66</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (11084-807-66) </PackageDescription>
<NDC11Code>11084-0807-66</NDC11Code>
<ProductNDC>11084-807</ProductNDC>
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<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11084-807-67</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 KIT (11084-807-67) / 1000 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>11084-0807-67</NDC11Code>
<ProductNDC>11084-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kindest Kare Advanced Antimicrobial Foam Handwash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11084-807-68</NDCCode>
<PackageDescription>2 CARTRIDGE in 1 BOX (11084-807-68) / 1000 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>11084-0807-68</NDC11Code>
<ProductNDC>11084-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kindest Kare Advanced Antimicrobial Foam Handwash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatments.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-807-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-807-01) > 25 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0807-01</NDC11Code>
<ProductNDC>11673-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Zinc Cold Remedy</ProprietaryName>
<NonProprietaryName>Zincum Aceticum, Zincum Gluconicum</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090612</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ZINC ACETATE; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>2; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13537-807-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-807-02) > 4 g in 1 TUBE (13537-807-01)</PackageDescription>
<NDC11Code>13537-0807-02</NDC11Code>
<ProductNDC>13537-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(fucsia Cautivante) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-807-01</NDCCode>
<PackageDescription>1 BAG in 1 CYLINDER (14783-807-01) > 10050 mL in 1 BAG</PackageDescription>
<NDC11Code>14783-0807-01</NDC11Code>
<ProductNDC>14783-807</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Avobenzone, Ensulizole, Octocrylene, And Octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<StartMarketingDate>20150624</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>AVOBENZONE; ENSULIZOLE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>.03; .025; .053; .05</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15127-807-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (15127-807-08) </PackageDescription>
<NDC11Code>15127-0807-08</NDC11Code>
<ProductNDC>15127-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen Extra Strength</ProprietaryName>
<ProprietaryNameSuffix>Rapid Burst Cherry</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100908</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Select Brand Dist.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100908</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-807-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (16714-807-01) </PackageDescription>
<NDC11Code>16714-0807-01</NDC11Code>
<ProductNDC>16714-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040480</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5; 5; 5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. In addition, each tablet for oral administration contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized corn starch. The 5 mg, 7.5 mg and 10 mg tablets contain D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake. The 12.5 mg, 15 mg, 20 mg, and 30 mg tablets contain D&C Yellow #10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>16729-267-63</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>16729-0267-63</NDC11Code>
<ProductNDC>16729-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130530</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201195</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5) .</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula:. Docetaxel is a white to off-white powder with an empirical formula of C 43H 53NO 14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. One-vial Docetaxel Injection. Docetaxel Injection USP is a sterile, non-pyrogenic, pale-yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel anhydrous USP, in 4 mg anhydrous citric acid for pH adjustment, 520 mg polysorbate 80 and 395 mg dehydrated alcohol solution. Docetaxel Injection USP is available in multiple dose (20 mg/mL, 80 mg/4 mL and 160 mg/8 mL) vials containing 20 mg (1 mL), 80 mg (4 mL) or 160 mg (8 mL) docetaxel anhydrous USP. Docetaxel Injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>16729-267-64</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>16729-0267-64</NDC11Code>
<ProductNDC>16729-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130530</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201195</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5) .</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula:. Docetaxel is a white to off-white powder with an empirical formula of C 43H 53NO 14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. One-vial Docetaxel Injection. Docetaxel Injection USP is a sterile, non-pyrogenic, pale-yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel anhydrous USP, in 4 mg anhydrous citric acid for pH adjustment, 520 mg polysorbate 80 and 395 mg dehydrated alcohol solution. Docetaxel Injection USP is available in multiple dose (20 mg/mL, 80 mg/4 mL and 160 mg/8 mL) vials containing 20 mg (1 mL), 80 mg (4 mL) or 160 mg (8 mL) docetaxel anhydrous USP. Docetaxel Injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>16729-267-65</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-65) / 8 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>16729-0267-65</NDC11Code>
<ProductNDC>16729-267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130530</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201195</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1) , 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2) , 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer ( 1.3) , 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4) , 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5) .</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula:. Docetaxel is a white to off-white powder with an empirical formula of C 43H 53NO 14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. One-vial Docetaxel Injection. Docetaxel Injection USP is a sterile, non-pyrogenic, pale-yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel anhydrous USP, in 4 mg anhydrous citric acid for pH adjustment, 520 mg polysorbate 80 and 395 mg dehydrated alcohol solution. Docetaxel Injection USP is available in multiple dose (20 mg/mL, 80 mg/4 mL and 160 mg/8 mL) vials containing 20 mg (1 mL), 80 mg (4 mL) or 160 mg (8 mL) docetaxel anhydrous USP. Docetaxel Injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
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