{
"NDC": [
{
"NDCCode": "69423-287-91",
"PackageDescription": "913 mL in 1 BOTTLE, PLASTIC (69423-287-91) ",
"NDC11Code": "69423-0287-91",
"ProductNDC": "69423-287",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Safeguard Antibacterial Hand Wash",
"ProprietaryNameSuffix": "Fresh Clean Scent",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230127",
"EndMarketingDate": "20251101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230127",
"EndMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "69423-287-45",
"PackageDescription": "458 mL in 1 BOTTLE, PUMP (69423-287-45) ",
"NDC11Code": "69423-0287-45",
"ProductNDC": "69423-287",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Safeguard Antibacterial Hand Wash",
"ProprietaryNameSuffix": "Fresh Clean Scent",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230127",
"EndMarketingDate": "20251101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230127",
"EndMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "45802-711-91",
"PackageDescription": "6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00) ",
"NDC11Code": "45802-0711-91",
"ProductNDC": "45802-711",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolmitriptan",
"NonProprietaryName": "Zolmitriptan",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20211116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212469",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "ZOLMITRIPTAN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211116",
"SamplePackage": "N",
"IndicationAndUsage": "Zolmitriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: 1 Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks., 2 Zolmitriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of zolmitriptan have not been established for cluster headache., 4 Not recommended in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.2)].",
"Description": "Zolmitriptan Nasal Spray, USP contains zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure. The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. Zolmitriptan Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each Zolmitriptan Nasal Spray contains 2.5 mg or 5 mg of zolmitriptan in a 100-μL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP, benzalkonium chloride solution NF and purified water USP. Zolmitriptan Nasal Spray is hypertonic. The osmolarity of Zolmitriptan Nasal Spray for 2.5 mg is 358 to 396 mOsmol, and for 5 mg is 411 to 455 mOsmol."
},
{
"NDCCode": "0074-3878-01",
"PackageDescription": "10 POWDER, FOR SOLUTION in 1 CARTON (0074-3878-01) ",
"NDC11Code": "00074-3878-01",
"ProductNDC": "0074-3878",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emblaveo",
"NonProprietaryName": "Aztreonam And Avibactam",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217906",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "AVIBACTAM; AZTREONAM",
"StrengthNumber": ".5; 1.5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).",
"Description": "EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam. Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C13H17N5O8S2. Figure 1. Chemical structure of aztreonam. Avibactam. Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C7H10N3O6SNa. Figure 2. Chemical structure of avibactam sodium. EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial."
},
{
"NDCCode": "0074-3878-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01) ",
"NDC11Code": "00074-3878-10",
"ProductNDC": "0074-3878",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emblaveo",
"NonProprietaryName": "Aztreonam And Avibactam",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250207",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217906",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "AZTREONAM; AVIBACTAM",
"StrengthNumber": "127; 42.3",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250207",
"SamplePackage": "N",
"IndicationAndUsage": "EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).",
"Description": "EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam. Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C13H17N5O8S2. Figure 1. Chemical structure of aztreonam. Avibactam. Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C7H10N3O6SNa. Figure 2. Chemical structure of avibactam sodium. EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial."
},
{
"NDCCode": "0093-1118-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1118-01) ",
"NDC11Code": "00093-1118-01",
"ProductNDC": "0093-1118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075665",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000817",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated. * For relief of signs and symptoms of juvenile arthritis. * For relief of the signs and symptoms of rheumatoid arthritis. * For relief of the signs and symptoms of osteoarthritis.",
"Description": "Etodolac extended-release tablets, USP contain etodolac USP, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac USP, for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has the following structural formula. C17H21NO3 M.W. 287.37. The inactive ingredients in etodolac extended-release tablets, USP are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow."
},
{
"NDCCode": "0093-1122-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1122-01) ",
"NDC11Code": "00093-1122-01",
"ProductNDC": "0093-1122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20010209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075665",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010209",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated. * For relief of signs and symptoms of juvenile arthritis. * For relief of the signs and symptoms of rheumatoid arthritis. * For relief of the signs and symptoms of osteoarthritis.",
"Description": "Etodolac extended-release tablets, USP contain etodolac USP, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac USP, for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has the following structural formula. C17H21NO3 M.W. 287.37. The inactive ingredients in etodolac extended-release tablets, USP are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow."
},
{
"NDCCode": "0093-7172-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7172-01) ",
"NDC11Code": "00093-7172-01",
"ProductNDC": "0093-7172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075665",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000811",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated. * For relief of signs and symptoms of juvenile arthritis. * For relief of the signs and symptoms of rheumatoid arthritis. * For relief of the signs and symptoms of osteoarthritis.",
"Description": "Etodolac extended-release tablets, USP contain etodolac USP, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac USP, for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has the following structural formula. C17H21NO3 M.W. 287.37. The inactive ingredients in etodolac extended-release tablets, USP are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow."
},
{
"NDCCode": "0185-0675-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (0185-0675-01) ",
"NDC11Code": "00185-0675-01",
"ProductNDC": "0185-0675",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150420",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074903",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150420",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:1.Osteoarthritis2.Rheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac tablets, USP are a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac, USP is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3 and it has the following structural formula. Each tablet, for oral administration contains 400 mg and 500 mg of etodolac, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), talc and titanium dioxide."
},
{
"NDCCode": "0185-0675-10",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (0185-0675-10) ",
"NDC11Code": "00185-0675-10",
"ProductNDC": "0185-0675",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150420",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074903",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150420",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:1.Osteoarthritis2.Rheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac tablets, USP are a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac, USP is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3 and it has the following structural formula. Each tablet, for oral administration contains 400 mg and 500 mg of etodolac, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), talc and titanium dioxide."
},
{
"NDCCode": "0185-0687-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (0185-0687-01) ",
"NDC11Code": "00185-0687-01",
"ProductNDC": "0185-0687",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150420",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074903",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150420",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:1.Osteoarthritis2.Rheumatoid arthritis, 2 For the management of acute pain.",
"Description": "Etodolac tablets, USP are a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac, USP is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3 and it has the following structural formula. Each tablet, for oral administration contains 400 mg and 500 mg of etodolac, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), talc and titanium dioxide."
},
{
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"NDC11Code": "00378-1743-01",
"ProductNDC": "0378-1743",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078183",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "212.6; 287.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "0378-1743-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1743-05)",
"NDC11Code": "00378-1743-05",
"ProductNDC": "0378-1743",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078183",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "212.6; 287.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "0378-1743-89",
"PackageDescription": "50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1743-89) ",
"NDC11Code": "00378-1743-89",
"ProductNDC": "0378-1743",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
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"EndMarketingDate": "20200131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078183",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN",
"StrengthNumber": "287.5; 212.6",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-05-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070322",
"EndMarketingDatePackage": "20200131",
"SamplePackage": "N"
},
{
"NDCCode": "0407-0690-05",
"PackageDescription": "10 VIAL in 1 BOX (0407-0690-05) / 5 mL in 1 VIAL",
"NDC11Code": "00407-0690-05",
"ProductNDC": "0407-0690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omniscan",
"NonProprietaryName": "Gadodiamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20020419",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020123",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "GADODIAMIDE",
"StrengthNumber": "287",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020419",
"EndMarketingDatePackage": "20250727",
"SamplePackage": "N",
"IndicationAndUsage": "OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).",
"Description": "OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use."
},
{
"NDCCode": "0407-0690-10",
"PackageDescription": "10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL",
"NDC11Code": "00407-0690-10",
"ProductNDC": "0407-0690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omniscan",
"NonProprietaryName": "Gadodiamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20020419",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020123",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "GADODIAMIDE",
"StrengthNumber": "287",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020419",
"SamplePackage": "N",
"IndicationAndUsage": "OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).",
"Description": "OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use."
},
{
"NDCCode": "0407-0690-12",
"PackageDescription": "10 SYRINGE, PLASTIC in 1 BOX (0407-0690-12) > 10 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00407-0690-12",
"ProductNDC": "0407-0690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omniscan",
"NonProprietaryName": "Gadodiamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20020419",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020123",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "GADODIAMIDE",
"StrengthNumber": "287",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20020419",
"SamplePackage": "N"
},
{
"NDCCode": "0407-0690-15",
"PackageDescription": "10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL",
"NDC11Code": "00407-0690-15",
"ProductNDC": "0407-0690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omniscan",
"NonProprietaryName": "Gadodiamide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20020419",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020123",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "GADODIAMIDE",
"StrengthNumber": "287",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20020419",
"SamplePackage": "N",
"IndicationAndUsage": "OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).",
"Description": "OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use."
},
{
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"PackageDescription": "10 SYRINGE, PLASTIC in 1 BOX (0407-0690-17) > 15 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00407-0690-17",
"ProductNDC": "0407-0690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omniscan",
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"RouteName": "INTRAVENOUS",
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"ApplicationNumber": "NDA020123",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "GADODIAMIDE",
"StrengthNumber": "287",
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"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20020419",
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},
{
"NDCCode": "0407-0690-20",
"PackageDescription": "10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL",
"NDC11Code": "00407-0690-20",
"ProductNDC": "0407-0690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omniscan",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20020419",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020123",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "GADODIAMIDE",
"StrengthNumber": "287",
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"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
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"IndicationAndUsage": "OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).",
"Description": "OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use."
},
{
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"LabelerName": "GE Healthcare Inc.",
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},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "GE Healthcare Inc.",
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"IndicationAndUsage": "OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).",
"Description": "OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use."
},
{
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"IndicationAndUsage": "OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).",
"Description": "OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use."
},
{
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"PackageNdcExcludeFlag": "N",
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},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "GE Healthcare Inc.",
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"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
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},
{
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"ProductNdcExcludeFlag": "N",
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"NDCCode": "0407-0690-70",
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"RouteName": "INTRAVENOUS",
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"ApplicationNumber": "NDA020123",
"LabelerName": "GE Healthcare Inc.",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060921",
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{
"NDCCode": "0407-0691-64",
"PackageDescription": "10 SYRINGE in 1 BOX (0407-0691-64) > 15 mL in 1 SYRINGE",
"NDC11Code": "00407-0691-64",
"ProductNDC": "0407-0691",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "INTRAVENOUS",
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"LabelerName": "GE Healthcare Inc.",
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<NDCList>
<NDC>
<NDCCode>69423-287-91</NDCCode>
<PackageDescription>913 mL in 1 BOTTLE, PLASTIC (69423-287-91) </PackageDescription>
<NDC11Code>69423-0287-91</NDC11Code>
<ProductNDC>69423-287</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Safeguard Antibacterial Hand Wash</ProprietaryName>
<ProprietaryNameSuffix>Fresh Clean Scent</ProprietaryNameSuffix>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230127</StartMarketingDate>
<EndMarketingDate>20251101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230127</StartMarketingDatePackage>
<EndMarketingDatePackage>20251101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69423-287-45</NDCCode>
<PackageDescription>458 mL in 1 BOTTLE, PUMP (69423-287-45) </PackageDescription>
<NDC11Code>69423-0287-45</NDC11Code>
<ProductNDC>69423-287</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Safeguard Antibacterial Hand Wash</ProprietaryName>
<ProprietaryNameSuffix>Fresh Clean Scent</ProprietaryNameSuffix>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230127</StartMarketingDate>
<EndMarketingDate>20251101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230127</StartMarketingDatePackage>
<EndMarketingDatePackage>20251101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-711-91</NDCCode>
<PackageDescription>6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00) </PackageDescription>
<NDC11Code>45802-0711-91</NDC11Code>
<ProductNDC>45802-711</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolmitriptan</ProprietaryName>
<NonProprietaryName>Zolmitriptan</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20211116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212469</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>ZOLMITRIPTAN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolmitriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: 1 Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks., 2 Zolmitriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of zolmitriptan have not been established for cluster headache., 4 Not recommended in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Zolmitriptan Nasal Spray, USP contains zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure. The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. Zolmitriptan Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each Zolmitriptan Nasal Spray contains 2.5 mg or 5 mg of zolmitriptan in a 100-μL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP, benzalkonium chloride solution NF and purified water USP. Zolmitriptan Nasal Spray is hypertonic. The osmolarity of Zolmitriptan Nasal Spray for 2.5 mg is 358 to 396 mOsmol, and for 5 mg is 411 to 455 mOsmol.</Description>
</NDC>
<NDC>
<NDCCode>0074-3878-01</NDCCode>
<PackageDescription>10 POWDER, FOR SOLUTION in 1 CARTON (0074-3878-01) </PackageDescription>
<NDC11Code>00074-3878-01</NDC11Code>
<ProductNDC>0074-3878</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emblaveo</ProprietaryName>
<NonProprietaryName>Aztreonam And Avibactam</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217906</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>AVIBACTAM; AZTREONAM</SubstanceName>
<StrengthNumber>.5; 1.5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).</IndicationAndUsage>
<Description>EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam. Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C13H17N5O8S2. Figure 1. Chemical structure of aztreonam. Avibactam. Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C7H10N3O6SNa. Figure 2. Chemical structure of avibactam sodium. EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial.</Description>
</NDC>
<NDC>
<NDCCode>0074-3878-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01) </PackageDescription>
<NDC11Code>00074-3878-10</NDC11Code>
<ProductNDC>0074-3878</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emblaveo</ProprietaryName>
<NonProprietaryName>Aztreonam And Avibactam</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250207</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217906</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>AZTREONAM; AVIBACTAM</SubstanceName>
<StrengthNumber>127; 42.3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).</IndicationAndUsage>
<Description>EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam. Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C13H17N5O8S2. Figure 1. Chemical structure of aztreonam. Avibactam. Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C7H10N3O6SNa. Figure 2. Chemical structure of avibactam sodium. EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial.</Description>
</NDC>
<NDC>
<NDCCode>0093-1118-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1118-01) </PackageDescription>
<NDC11Code>00093-1118-01</NDC11Code>
<ProductNDC>0093-1118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075665</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated. * For relief of signs and symptoms of juvenile arthritis. * For relief of the signs and symptoms of rheumatoid arthritis. * For relief of the signs and symptoms of osteoarthritis.</IndicationAndUsage>
<Description>Etodolac extended-release tablets, USP contain etodolac USP, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac USP, for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has the following structural formula. C17H21NO3 M.W. 287.37. The inactive ingredients in etodolac extended-release tablets, USP are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0093-1122-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1122-01) </PackageDescription>
<NDC11Code>00093-1122-01</NDC11Code>
<ProductNDC>0093-1122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075665</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated. * For relief of signs and symptoms of juvenile arthritis. * For relief of the signs and symptoms of rheumatoid arthritis. * For relief of the signs and symptoms of osteoarthritis.</IndicationAndUsage>
<Description>Etodolac extended-release tablets, USP contain etodolac USP, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac USP, for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has the following structural formula. C17H21NO3 M.W. 287.37. The inactive ingredients in etodolac extended-release tablets, USP are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0093-7172-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7172-01) </PackageDescription>
<NDC11Code>00093-7172-01</NDC11Code>
<ProductNDC>0093-7172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075665</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated. * For relief of signs and symptoms of juvenile arthritis. * For relief of the signs and symptoms of rheumatoid arthritis. * For relief of the signs and symptoms of osteoarthritis.</IndicationAndUsage>
<Description>Etodolac extended-release tablets, USP contain etodolac USP, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac USP, for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has the following structural formula. C17H21NO3 M.W. 287.37. The inactive ingredients in etodolac extended-release tablets, USP are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0185-0675-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (0185-0675-01) </PackageDescription>
<NDC11Code>00185-0675-01</NDC11Code>
<ProductNDC>0185-0675</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150420</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074903</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150420</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:1.Osteoarthritis2.Rheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac tablets, USP are a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac, USP is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3 and it has the following structural formula. Each tablet, for oral administration contains 400 mg and 500 mg of etodolac, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0185-0675-10</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (0185-0675-10) </PackageDescription>
<NDC11Code>00185-0675-10</NDC11Code>
<ProductNDC>0185-0675</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150420</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074903</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150420</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:1.Osteoarthritis2.Rheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac tablets, USP are a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac, USP is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3 and it has the following structural formula. Each tablet, for oral administration contains 400 mg and 500 mg of etodolac, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0185-0687-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (0185-0687-01) </PackageDescription>
<NDC11Code>00185-0687-01</NDC11Code>
<ProductNDC>0185-0687</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150420</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074903</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150420</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:1.Osteoarthritis2.Rheumatoid arthritis, 2 For the management of acute pain.</IndicationAndUsage>
<Description>Etodolac tablets, USP are a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac, USP is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3 and it has the following structural formula. Each tablet, for oral administration contains 400 mg and 500 mg of etodolac, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-1743-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1743-01)</PackageDescription>
<NDC11Code>00378-1743-01</NDC11Code>
<ProductNDC>0378-1743</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078183</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>212.6; 287.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-1743-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1743-05)</PackageDescription>
<NDC11Code>00378-1743-05</NDC11Code>
<ProductNDC>0378-1743</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078183</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>212.6; 287.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-1743-89</NDCCode>
<PackageDescription>50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1743-89) </PackageDescription>
<NDC11Code>00378-1743-89</NDC11Code>
<ProductNDC>0378-1743</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070322</StartMarketingDate>
<EndMarketingDate>20200131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078183</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN</SubstanceName>
<StrengthNumber>287.5; 212.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070322</StartMarketingDatePackage>
<EndMarketingDatePackage>20200131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0407-0690-05</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (0407-0690-05) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00407-0690-05</NDC11Code>
<ProductNDC>0407-0690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omniscan</ProprietaryName>
<NonProprietaryName>Gadodiamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20020419</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020123</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>GADODIAMIDE</SubstanceName>
<StrengthNumber>287</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020419</StartMarketingDatePackage>
<EndMarketingDatePackage>20250727</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
<Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
</NDC>
<NDC>
<NDCCode>0407-0690-10</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00407-0690-10</NDC11Code>
<ProductNDC>0407-0690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omniscan</ProprietaryName>
<NonProprietaryName>Gadodiamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20020419</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020123</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>GADODIAMIDE</SubstanceName>
<StrengthNumber>287</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
<Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
</NDC>
<NDC>
<NDCCode>0407-0690-12</NDCCode>
<PackageDescription>10 SYRINGE, PLASTIC in 1 BOX (0407-0690-12) > 10 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00407-0690-12</NDC11Code>
<ProductNDC>0407-0690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omniscan</ProprietaryName>
<NonProprietaryName>Gadodiamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20020419</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020123</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>GADODIAMIDE</SubstanceName>
<StrengthNumber>287</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0407-0690-15</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>00407-0690-15</NDC11Code>
<ProductNDC>0407-0690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omniscan</ProprietaryName>
<NonProprietaryName>Gadodiamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20020419</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020123</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>GADODIAMIDE</SubstanceName>
<StrengthNumber>287</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
<Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
</NDC>
<NDC>
<NDCCode>0407-0690-17</NDCCode>
<PackageDescription>10 SYRINGE, PLASTIC in 1 BOX (0407-0690-17) > 15 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00407-0690-17</NDC11Code>
<ProductNDC>0407-0690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omniscan</ProprietaryName>
<NonProprietaryName>Gadodiamide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20020419</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020123</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>GADODIAMIDE</SubstanceName>
<StrengthNumber>287</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020419</StartMarketingDatePackage>
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<IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
<Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
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<IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
<Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
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<IndicationAndUsage>OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: 1 Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1), 2 Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2).</IndicationAndUsage>
<Description>OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9∙xH2O, and the following structural formula. Pertinent physicochemical data for OMNISCAN are noted below. OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2018-05-10</LastUpdate>
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<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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