RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "63304-094-86",
      "PackageDescription": "4 BLISTER PACK in 1 BOX (63304-094-86)  / 7 CAPSULE in 1 BLISTER PACK (63304-094-11) ",
      "NDC11Code": "63304-0094-86",
      "ProductNDC": "63304-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213914",
      "LabelerName": "Sun Pharmaceutical Industries Inc.",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac."
    },
    {
      "NDCCode": "63304-094-27",
      "PackageDescription": "28 CAPSULE in 1 BOTTLE (63304-094-27) ",
      "NDC11Code": "63304-0094-27",
      "ProductNDC": "63304-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213914",
      "LabelerName": "Sun Pharmaceutical Industries Inc.",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac."
    },
    {
      "NDCCode": "63304-091-86",
      "PackageDescription": "4 BLISTER PACK in 1 BOX (63304-091-86)  / 7 CAPSULE in 1 BLISTER PACK (63304-091-11) ",
      "NDC11Code": "63304-0091-86",
      "ProductNDC": "63304-091",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213914",
      "LabelerName": "Sun Pharmaceutical Industries Inc.",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac."
    },
    {
      "NDCCode": "63304-092-86",
      "PackageDescription": "4 BLISTER PACK in 1 BOX (63304-092-86)  / 7 CAPSULE in 1 BLISTER PACK (63304-092-11) ",
      "NDC11Code": "63304-0092-86",
      "ProductNDC": "63304-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213914",
      "LabelerName": "Sun Pharmaceutical Industries Inc.",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac."
    },
    {
      "NDCCode": "63304-093-86",
      "PackageDescription": "4 BLISTER PACK in 1 BOX (63304-093-86)  / 7 CAPSULE in 1 BLISTER PACK (63304-093-11) ",
      "NDC11Code": "63304-0093-86",
      "ProductNDC": "63304-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sunitinib Malate",
      "NonProprietaryName": "Sunitinib Malate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213914",
      "LabelerName": "Sun Pharmaceutical Industries Inc.",
      "SubstanceName": "SUNITINIB MALATE",
      "StrengthNumber": "37.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191225",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).",
      "Description": "Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac."
    },
    {
      "NDCCode": "72572-094-10",
      "PackageDescription": "10 VIAL in 1 CARTON (72572-094-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "72572-0094-10",
      "ProductNDC": "72572-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin Sodium",
      "NonProprietaryName": "Ampicillin Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20250908",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201025",
      "LabelerName": "Civica, Inc.",
      "SubstanceName": "AMPICILLIN SODIUM",
      "StrengthNumber": "2",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250908",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infectionscaused by Streptococcus pneumoniae, Staphylococcus aureus(penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitiscaused by E. coli, Group B streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcusspp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilisand Salmonellaspp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infectionscaused by sensitive strains of E. coliand Proteus mirabilis. Gastrointestinal Infectionscaused by Salmonella typhi (typhoid fever), other Salmonellaspp., and Shigellaspp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection, USP and other antibacterial drugs, ampicillin for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
      "Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α, 5α, 6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a white to off-white crystalline sterile powder and forms a clear colorless solution upon reconstitution with sterile water for injection, USP or Bacteriostatic water for injection, USP. Each vial of ampicillin for injection, USP contains ampicillin sodium equivalent to  1 gram or 2 grams ampicillin. The sodium content is  65.83 mg (2.86 mEq) per 1 g, 131.66 mg (5.72 mEq) per 2 g of ampicillin. It has the following molecular structure. The molecular formula is C 16H 18N 3NaO 4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
    },
    {
      "NDCCode": "87063-094-00",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (87063-094-00) ",
      "NDC11Code": "87063-0094-00",
      "ProductNDC": "87063-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212399",
      "LabelerName": "ASCLEMED USA INC.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": "300",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
    },
    {
      "NDCCode": "87063-094-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (87063-094-30) ",
      "NDC11Code": "87063-0094-30",
      "ProductNDC": "87063-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212399",
      "LabelerName": "ASCLEMED USA INC.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": "300",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
    },
    {
      "NDCCode": "87063-094-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (87063-094-60) ",
      "NDC11Code": "87063-0094-60",
      "ProductNDC": "87063-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212399",
      "LabelerName": "ASCLEMED USA INC.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": "300",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
    },
    {
      "NDCCode": "87063-094-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (87063-094-90) ",
      "NDC11Code": "87063-0094-90",
      "ProductNDC": "87063-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levothyroxine Sodium",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212399",
      "LabelerName": "ASCLEMED USA INC.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": "300",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260206",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
      "Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
    },
    {
      "NDCCode": "0049-0013-83",
      "PackageDescription": "10 VIAL in 1 CARTON (0049-0013-83)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0013-81) ",
      "NDC11Code": "00049-0013-83",
      "ProductNDC": "0049-0013",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Unasyn",
      "NonProprietaryName": "Ampicillin Sodium And Sulbactam Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19911122",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050608",
      "LabelerName": "Roerig",
      "SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
      "StrengthNumber": "1; .5",
      "StrengthUnit": "g/1; g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19911122",
      "SamplePackage": "N",
      "IndicationAndUsage": "UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus. NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp. (including B. fragilis), and Enterobacter spp. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis). While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to UNASYN. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of UNASYN and other antibacterial drugs, UNASYN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "UNASYN (ampicillin and sulbactam) for injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. UNASYN is available as a white to off-white dry powder for reconstitution. UNASYN dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g vial contains ampicillin 1 g and sulbactam 0.5 g (equivalent to 1.063 g ampicillin sodium and 0.547 g sulbactam sodium). Each 1.5 g vial contains approximately 115 mg of sodium. Each 3 g vial contains ampicillin 2 g and sulbactam 1 g (equivalent to 2.125 g ampicillin sodium and 1.094 g sulbactam sodium). Each 3 g vial contains approximately 230 mg of sodium."
    },
    {
      "NDCCode": "0049-0014-83",
      "PackageDescription": "10 VIAL in 1 CARTON (0049-0014-83)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81) ",
      "NDC11Code": "00049-0014-83",
      "ProductNDC": "0049-0014",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Unasyn",
      "NonProprietaryName": "Ampicillin Sodium And Sulbactam Sodium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19911122",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050608",
      "LabelerName": "Roerig",
      "SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
      "StrengthNumber": "2; 1",
      "StrengthUnit": "g/1; g/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19911122",
      "SamplePackage": "N",
      "IndicationAndUsage": "UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus. NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp. (including B. fragilis), and Enterobacter spp. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis). While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to UNASYN. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of UNASYN and other antibacterial drugs, UNASYN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "UNASYN (ampicillin and sulbactam) for injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. UNASYN is available as a white to off-white dry powder for reconstitution. UNASYN dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g vial contains ampicillin 1 g and sulbactam 0.5 g (equivalent to 1.063 g ampicillin sodium and 0.547 g sulbactam sodium). Each 1.5 g vial contains approximately 115 mg of sodium. Each 3 g vial contains ampicillin 2 g and sulbactam 1 g (equivalent to 2.125 g ampicillin sodium and 1.094 g sulbactam sodium). Each 3 g vial contains approximately 230 mg of sodium."
    },
    {
      "NDCCode": "0597-0155-28",
      "PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0155-28)  / 28 SPRAY, METERED in 1 CARTRIDGE",
      "NDC11Code": "00597-0155-28",
      "ProductNDC": "0597-0155",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stiolto Respimat",
      "NonProprietaryName": "Tiotropium Bromide And Olodaterol",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20150521",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206756",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "TIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE",
      "StrengthNumber": "3.124; 2.736",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150521",
      "SamplePackage": "N",
      "IndicationAndUsage": "STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1). Important limitations: 1 STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. (1.1), 2 STIOLTO RESPIMAT is NOT indicated to treat asthma. (1.1).",
      "Description": "STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA). The drug substance tiotropium bromide monohydrate is chemically described as (1α, 2ß, 4ß, 5α, 7ß)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug substance olodaterol hydrochloride is chemically described as 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]-amino]ethyl]-, monohydrochloride. Olodaterol hydrochloride is a white to off-white powder that is sparingly-slightly soluble in water and slightly soluble in ethanol. The molecular weight is 422.9 g/mole (salt): 386.5 g/mole (base), and the molecular formula is C21H26N2O5 × HCl as a hydrochloride. The conversion factor from salt to free base is 1.094. The structural formula is. The drug product, STIOLTO RESPIMAT, is composed of a sterile aqueous solution of tiotropium bromide and olodaterol hydrochloride filled into a 4.5 mL plastic container crimped into an aluminum cylinder (STIOLTO RESPIMAT cartridge) for use with the STIOLTO RESPIMAT inhaler. Excipients include, benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. The STIOLTO RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. The STIOLTO RESPIMAT inhaler has a light green-colored cap. When used with the STIOLTO RESPIMAT inhaler each cartridge, containing 4 grams of sterile aqueous solution, delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the STIOLTO RESPIMAT inhaler delivers 5 mcg tiotropium (equivalent to 6.247 mcg tiotropium bromide monohydrate) and 5 mcg olodaterol (equivalent to 5.473 mcg olodaterol hydrochloride) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds)."
    },
    {
      "NDCCode": "0597-0155-61",
      "PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0155-61)  / 60 SPRAY, METERED in 1 CARTRIDGE",
      "NDC11Code": "00597-0155-61",
      "ProductNDC": "0597-0155",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stiolto Respimat",
      "NonProprietaryName": "Tiotropium Bromide And Olodaterol",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20150521",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206756",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "TIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE",
      "StrengthNumber": "3.124; 2.736",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150521",
      "SamplePackage": "N",
      "IndicationAndUsage": "STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1). Important limitations: 1 STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. (1.1), 2 STIOLTO RESPIMAT is NOT indicated to treat asthma. (1.1).",
      "Description": "STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA). The drug substance tiotropium bromide monohydrate is chemically described as (1α, 2ß, 4ß, 5α, 7ß)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug substance olodaterol hydrochloride is chemically described as 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]-amino]ethyl]-, monohydrochloride. Olodaterol hydrochloride is a white to off-white powder that is sparingly-slightly soluble in water and slightly soluble in ethanol. The molecular weight is 422.9 g/mole (salt): 386.5 g/mole (base), and the molecular formula is C21H26N2O5 × HCl as a hydrochloride. The conversion factor from salt to free base is 1.094. The structural formula is. The drug product, STIOLTO RESPIMAT, is composed of a sterile aqueous solution of tiotropium bromide and olodaterol hydrochloride filled into a 4.5 mL plastic container crimped into an aluminum cylinder (STIOLTO RESPIMAT cartridge) for use with the STIOLTO RESPIMAT inhaler. Excipients include, benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. The STIOLTO RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. The STIOLTO RESPIMAT inhaler has a light green-colored cap. When used with the STIOLTO RESPIMAT inhaler each cartridge, containing 4 grams of sterile aqueous solution, delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the STIOLTO RESPIMAT inhaler delivers 5 mcg tiotropium (equivalent to 6.247 mcg tiotropium bromide monohydrate) and 5 mcg olodaterol (equivalent to 5.473 mcg olodaterol hydrochloride) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds)."
    },
    {
      "NDCCode": "0597-0155-70",
      "PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0155-70)  / 10 SPRAY, METERED in 1 CARTRIDGE",
      "NDC11Code": "00597-0155-70",
      "ProductNDC": "0597-0155",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stiolto Respimat",
      "NonProprietaryName": "Tiotropium Bromide And Olodaterol",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20150521",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206756",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "TIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE",
      "StrengthNumber": "3.124; 2.736",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190322",
      "SamplePackage": "N",
      "IndicationAndUsage": "STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1). Important limitations: 1 STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. (1.1), 2 STIOLTO RESPIMAT is NOT indicated to treat asthma. (1.1).",
      "Description": "STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA). The drug substance tiotropium bromide monohydrate is chemically described as (1α, 2ß, 4ß, 5α, 7ß)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug substance olodaterol hydrochloride is chemically described as 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]-amino]ethyl]-, monohydrochloride. Olodaterol hydrochloride is a white to off-white powder that is sparingly-slightly soluble in water and slightly soluble in ethanol. The molecular weight is 422.9 g/mole (salt): 386.5 g/mole (base), and the molecular formula is C21H26N2O5 × HCl as a hydrochloride. The conversion factor from salt to free base is 1.094. The structural formula is. The drug product, STIOLTO RESPIMAT, is composed of a sterile aqueous solution of tiotropium bromide and olodaterol hydrochloride filled into a 4.5 mL plastic container crimped into an aluminum cylinder (STIOLTO RESPIMAT cartridge) for use with the STIOLTO RESPIMAT inhaler. Excipients include, benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. The STIOLTO RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. The STIOLTO RESPIMAT inhaler has a light green-colored cap. When used with the STIOLTO RESPIMAT inhaler each cartridge, containing 4 grams of sterile aqueous solution, delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the STIOLTO RESPIMAT inhaler delivers 5 mcg tiotropium (equivalent to 6.247 mcg tiotropium bromide monohydrate) and 5 mcg olodaterol (equivalent to 5.473 mcg olodaterol hydrochloride) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds)."
    },
    {
      "NDCCode": "0597-0192-61",
      "PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0192-61)  / 60 SPRAY, METERED in 1 CARTRIDGE",
      "NDC11Code": "00597-0192-61",
      "ProductNDC": "0597-0192",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Striverdi Respimat",
      "NonProprietaryName": "Olodaterol Respimat Inhalation Spray",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20140801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA203108",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "OLODATEROL HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140801",
      "SamplePackage": "N",
      "IndicationAndUsage": "STRIVERDI RESPIMAT Inhalation Spray is a long-acting beta2-adrenergic agonist (LABA) indicated for. The long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. (1.1). Important limitations: 1 STRIVERDI RESPIMAT is NOT indicated to treat acute deterioration of COPD. (1.2), 2 STRIVERDI RESPIMAT is NOT indicated to treat asthma. (1.2).",
      "Description": "The active moiety olodaterol is a selective beta2-adrenergic bronchodilator. The drug substance, olodaterol hydrochloride, is chemically described as 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]-amino]ethyl]-, monohydrochloride. Olodaterol hydrochloride is a white to off-white powder that is sparingly-slightly soluble in water and slightly soluble in ethanol. The molecular weight is 422.9 g/mole (salt): 386.5 g/mole (base), and the molecular formula is C21H26N2O5 × HCl as a hydrochloride. The conversion factor from salt to free base is 1.094. The structural formula is. The drug product, STRIVERDI RESPIMAT, is composed of a sterile, aqueous solution of olodaterol hydrochloride filled into a 4.5 mL plastic container crimped into an aluminum cylinder (STRIVERDI RESPIMAT cartridge) for use with the STRIVERDI RESPIMAT inhaler. Excipients include anhydrous citric acid, benzalkonium chloride, edetate disodium, and water for injection. The STRIVERDI RESPIMAT cartridge is only intended for use with the STRIVERDI RESPIMAT inhaler. The STRIVERDI RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. The STRIVERDI RESPIMAT inhaler has a yellow-colored cap. When used with the STRIVERDI RESPIMAT inhaler, each cartridge containing a minimum of 4 grams of a sterile aqueous solution delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the STRIVERDI RESPIMAT inhaler delivers 5 mcg olodaterol (equivalent to 5.473 mcg olodaterol hydrochloride) in 22.1 mcL of solution from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds). Prior to first use, the STRIVERDI RESPIMAT cartridge is inserted into the STRIVERDI RESPIMAT inhaler and the unit is primed. When using for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17)]."
    },
    {
      "NDCCode": "0641-6116-10",
      "PackageDescription": "10 VIAL in 1 CARTON (0641-6116-10)  / 1.5 g in 1 VIAL (0641-6116-01) ",
      "NDC11Code": "00641-6116-10",
      "ProductNDC": "0641-6116",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin And Sulbactam",
      "NonProprietaryName": "Ampicillin And Sulbactam",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065406",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
      "StrengthNumber": "1; .5",
      "StrengthUnit": "g/1.5g; g/1.5g",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091222",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus*. NOTE: For information on use in pediatric patients see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*,  and Bacteroides spp.* (including B. fragilis*). *Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g vial contains ampicillin 1 g and sulbactam 0.5 g (equivalent to 1.063 g ampicillin sodium and 0.547 g sulbactam sodium). Each 1.5 g vial contains approximately 115 mg of sodium. Each 3 g vial contains ampicillin 2 g and sulbactam 1 g (equivalent to 2.126 g ampicillin sodium and 1.094 g sulbactam sodium). Each 3 g vial contains approximately 230 mg of sodium."
    },
    {
      "NDCCode": "0641-6117-10",
      "PackageDescription": "10 VIAL in 1 CARTON (0641-6117-10)  / 3 g in 1 VIAL (0641-6117-01) ",
      "NDC11Code": "00641-6117-10",
      "ProductNDC": "0641-6117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ampicillin And Sulbactam",
      "NonProprietaryName": "Ampicillin And Sulbactam",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065406",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
      "StrengthNumber": "2; 1",
      "StrengthUnit": "g/3g; g/3g",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091222",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus*. NOTE: For information on use in pediatric patients see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*,  and Bacteroides spp.* (including B. fragilis*). *Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. Ampicillin and Sulbactam for Injection is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g vial contains ampicillin 1 g and sulbactam 0.5 g (equivalent to 1.063 g ampicillin sodium and 0.547 g sulbactam sodium). Each 1.5 g vial contains approximately 115 mg of sodium. Each 3 g vial contains ampicillin 2 g and sulbactam 1 g (equivalent to 2.126 g ampicillin sodium and 1.094 g sulbactam sodium). Each 3 g vial contains approximately 230 mg of sodium."
    },
    {
      "NDCCode": "10202-094-89",
      "PackageDescription": "18 BLISTER PACK in 1 CARTON (10202-094-89)  > 1 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "10202-0094-89",
      "ProductNDC": "10202-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "7 Select Nasal Decongestant Pe",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161007",
      "EndMarketingDate": "20201130",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "7-Eleven",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161007",
      "EndMarketingDatePackage": "20201130",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10544-094-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (10544-094-20)",
      "NDC11Code": "10544-0094-20",
      "ProductNDC": "10544-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Benzonatate",
      "NonProprietaryName": "Benzonatate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040749",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "BENZONATATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Benzonatate USP is indicated for the symptomatic relief of cough.",
      "Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide."
    },
    {
      "NDCCode": "10631-094-20",
      "PackageDescription": "1 TUBE in 1 CARTON (10631-094-20)  > 30 g in 1 TUBE",
      "NDC11Code": "10631-0094-20",
      "ProductNDC": "10631-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Halog",
      "NonProprietaryName": "Halcinonide Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "HALCINONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090210",
      "SamplePackage": "N",
      "IndicationAndUsage": "HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide."
    },
    {
      "NDCCode": "10631-094-30",
      "PackageDescription": "1 TUBE in 1 CARTON (10631-094-30)  > 60 g in 1 TUBE",
      "NDC11Code": "10631-0094-30",
      "ProductNDC": "10631-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Halog",
      "NonProprietaryName": "Halcinonide Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "HALCINONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090210",
      "SamplePackage": "N",
      "IndicationAndUsage": "HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide."
    },
    {
      "NDCCode": "10631-094-71",
      "PackageDescription": "4 TUBE in 1 CARTON (10631-094-71)  > 60 g in 1 TUBE",
      "NDC11Code": "10631-0094-71",
      "ProductNDC": "10631-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Halog",
      "NonProprietaryName": "Halcinonide Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "HALCINONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180702",
      "SamplePackage": "N",
      "IndicationAndUsage": "HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide."
    },
    {
      "NDCCode": "10631-094-76",
      "PackageDescription": "216 g in 1 JAR (10631-094-76) ",
      "NDC11Code": "10631-0094-76",
      "ProductNDC": "10631-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Halog",
      "NonProprietaryName": "Halcinonide Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017556",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "HALCINONIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090210",
      "SamplePackage": "N",
      "IndicationAndUsage": "HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
      "Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide, USP is designated chemically as 21-Chloro-9-fluoro-11β, 16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula. Each gram of 0.1% HALOG (Halcinonide Cream, USP) contains 1 mg halcinonide, USP in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, glyceryl monostearate, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide."
    },
    {
      "NDCCode": "10812-094-01",
      "PackageDescription": "9.9 g in 1 CONTAINER (10812-094-01)",
      "NDC11Code": "10812-0094-01",
      "ProductNDC": "10812-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Neutrogena Healthy Skin Compact Makeup",
      "ProprietaryNameSuffix": "Spf Nude 40",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101206",
      "EndMarketingDate": "20180901",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "28; 80; 40; 90; 40",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-05",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "11090-094-01",
      "PackageDescription": "1 TUBE in 1 CARTON (11090-094-01)  / 32 mL in 1 TUBE",
      "NDC11Code": "11090-0094-01",
      "ProductNDC": "11090-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "It Cosmetics Your Skin But Better Cc Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum Spf 50 Plus Clear Sunscreen-deep Honey",
      "NonProprietaryName": "Homosalate, Octisalate And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20221101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Beauty Manufacturing Solutions Corp.",
      "SubstanceName": "HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "100; 50; 40",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20221101",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "11489-094-01",
      "PackageDescription": "1 JAR in 1 CARTON (11489-094-01)  > 50 g in 1 JAR",
      "NDC11Code": "11489-0094-01",
      "ProductNDC": "11489-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Botanics Radiant Youth Protecting Day Cream Sunscreen Broad Spectrum Spf 15",
      "NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160630",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "BCM Ltd",
      "SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "1.5; 1.5; 2.5",
      "StrengthUnit": "g/50g; g/50g; g/50g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses."
    },
    {
      "NDCCode": "11673-094-23",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (11673-094-23)  > 18 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0094-23",
      "ProductNDC": "11673-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Nasal Decongestant Pe",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090612",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Target Corporation",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-18",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "11673-094-68",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (11673-094-68)  > 18 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0094-68",
      "ProductNDC": "11673-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Nasal Decongestant Pe",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090612",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Target Corporation",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-18",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "11673-094-89",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (11673-094-89)  > 18 TABLET in 1 BLISTER PACK",
      "NDC11Code": "11673-0094-89",
      "ProductNDC": "11673-094",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Up And Up Nasal Decongestant Pe",
      "NonProprietaryName": "Phenylephrine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090612",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Target Corporation",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-18",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"63304-094-86","ProprietaryName":"Sunitinib Malate","NonProprietaryName":"Sunitinib Malate"},{"NDCCode":"63304-094-27","ProprietaryName":"Sunitinib Malate","NonProprietaryName":"Sunitinib Malate"},{"NDCCode":"63304-091-86","ProprietaryName":"Sunitinib Malate","NonProprietaryName":"Sunitinib Malate"},{"NDCCode":"63304-092-86","ProprietaryName":"Sunitinib Malate","NonProprietaryName":"Sunitinib Malate"},{"NDCCode":"63304-093-86","ProprietaryName":"Sunitinib Malate","NonProprietaryName":"Sunitinib Malate"},{"NDCCode":"72572-094-10","ProprietaryName":"Ampicillin Sodium","NonProprietaryName":"Ampicillin Sodium"},{"NDCCode":"87063-094-00","ProprietaryName":"Levothyroxine Sodium","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"87063-094-30","ProprietaryName":"Levothyroxine Sodium","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"87063-094-60","ProprietaryName":"Levothyroxine Sodium","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"87063-094-90","ProprietaryName":"Levothyroxine Sodium","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"0049-0013-83","ProprietaryName":"Unasyn","NonProprietaryName":"Ampicillin Sodium And Sulbactam Sodium"},{"NDCCode":"0049-0014-83","ProprietaryName":"Unasyn","NonProprietaryName":"Ampicillin Sodium And Sulbactam Sodium"},{"NDCCode":"0597-0155-28","ProprietaryName":"Stiolto Respimat","NonProprietaryName":"Tiotropium Bromide And Olodaterol"},{"NDCCode":"0597-0155-61","ProprietaryName":"Stiolto Respimat","NonProprietaryName":"Tiotropium Bromide And Olodaterol"},{"NDCCode":"0597-0155-70","ProprietaryName":"Stiolto Respimat","NonProprietaryName":"Tiotropium Bromide And Olodaterol"},{"NDCCode":"0597-0192-61","ProprietaryName":"Striverdi Respimat","NonProprietaryName":"Olodaterol Respimat Inhalation Spray"},{"NDCCode":"0641-6116-10","ProprietaryName":"Ampicillin And Sulbactam","NonProprietaryName":"Ampicillin And Sulbactam"},{"NDCCode":"0641-6117-10","ProprietaryName":"Ampicillin And Sulbactam","NonProprietaryName":"Ampicillin And Sulbactam"},{"NDCCode":"10202-094-89","ProprietaryName":"7 Select Nasal Decongestant Pe","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"10544-094-20","ProprietaryName":"Benzonatate","NonProprietaryName":"Benzonatate"},{"NDCCode":"10631-094-20","ProprietaryName":"Halog","NonProprietaryName":"Halcinonide Cream"},{"NDCCode":"10631-094-30","ProprietaryName":"Halog","NonProprietaryName":"Halcinonide Cream"},{"NDCCode":"10631-094-71","ProprietaryName":"Halog","NonProprietaryName":"Halcinonide Cream"},{"NDCCode":"10631-094-76","ProprietaryName":"Halog","NonProprietaryName":"Halcinonide Cream"},{"NDCCode":"10812-094-01","ProprietaryName":"Neutrogena Healthy Skin Compact Makeup","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone"},{"NDCCode":"11090-094-01","ProprietaryName":"It Cosmetics Your Skin But Better Cc Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum Spf 50 Plus Clear Sunscreen-deep Honey","NonProprietaryName":"Homosalate, Octisalate And Octocrylene"},{"NDCCode":"11489-094-01","ProprietaryName":"Botanics Radiant Youth Protecting Day Cream Sunscreen Broad Spectrum Spf 15","NonProprietaryName":"Avobenzone, Octisalate, Octocrylene"},{"NDCCode":"11673-094-23","ProprietaryName":"Up And Up Nasal Decongestant Pe","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"11673-094-68","ProprietaryName":"Up And Up Nasal Decongestant Pe","NonProprietaryName":"Phenylephrine Hydrochloride"},{"NDCCode":"11673-094-89","ProprietaryName":"Up And Up Nasal Decongestant Pe","NonProprietaryName":"Phenylephrine Hydrochloride"}]}
                    

<NDCList><NDC><NDCCode>63304-094-86</NDCCode><ProprietaryName>Sunitinib Malate</ProprietaryName><NonProprietaryName>Sunitinib Malate</NonProprietaryName></NDC><NDC><NDCCode>63304-094-27</NDCCode><ProprietaryName>Sunitinib Malate</ProprietaryName><NonProprietaryName>Sunitinib Malate</NonProprietaryName></NDC><NDC><NDCCode>63304-091-86</NDCCode><ProprietaryName>Sunitinib Malate</ProprietaryName><NonProprietaryName>Sunitinib Malate</NonProprietaryName></NDC><NDC><NDCCode>63304-092-86</NDCCode><ProprietaryName>Sunitinib Malate</ProprietaryName><NonProprietaryName>Sunitinib Malate</NonProprietaryName></NDC><NDC><NDCCode>63304-093-86</NDCCode><ProprietaryName>Sunitinib Malate</ProprietaryName><NonProprietaryName>Sunitinib Malate</NonProprietaryName></NDC><NDC><NDCCode>72572-094-10</NDCCode><ProprietaryName>Ampicillin Sodium</ProprietaryName><NonProprietaryName>Ampicillin Sodium</NonProprietaryName></NDC><NDC><NDCCode>87063-094-00</NDCCode><ProprietaryName>Levothyroxine Sodium</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>87063-094-30</NDCCode><ProprietaryName>Levothyroxine Sodium</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>87063-094-60</NDCCode><ProprietaryName>Levothyroxine Sodium</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>87063-094-90</NDCCode><ProprietaryName>Levothyroxine Sodium</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>0049-0013-83</NDCCode><ProprietaryName>Unasyn</ProprietaryName><NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName></NDC><NDC><NDCCode>0049-0014-83</NDCCode><ProprietaryName>Unasyn</ProprietaryName><NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName></NDC><NDC><NDCCode>0597-0155-28</NDCCode><ProprietaryName>Stiolto Respimat</ProprietaryName><NonProprietaryName>Tiotropium Bromide And Olodaterol</NonProprietaryName></NDC><NDC><NDCCode>0597-0155-61</NDCCode><ProprietaryName>Stiolto Respimat</ProprietaryName><NonProprietaryName>Tiotropium Bromide And Olodaterol</NonProprietaryName></NDC><NDC><NDCCode>0597-0155-70</NDCCode><ProprietaryName>Stiolto Respimat</ProprietaryName><NonProprietaryName>Tiotropium Bromide And Olodaterol</NonProprietaryName></NDC><NDC><NDCCode>0597-0192-61</NDCCode><ProprietaryName>Striverdi Respimat</ProprietaryName><NonProprietaryName>Olodaterol Respimat Inhalation Spray</NonProprietaryName></NDC><NDC><NDCCode>0641-6116-10</NDCCode><ProprietaryName>Ampicillin And Sulbactam</ProprietaryName><NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName></NDC><NDC><NDCCode>0641-6117-10</NDCCode><ProprietaryName>Ampicillin And Sulbactam</ProprietaryName><NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName></NDC><NDC><NDCCode>10202-094-89</NDCCode><ProprietaryName>7 Select Nasal Decongestant Pe</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10544-094-20</NDCCode><ProprietaryName>Benzonatate</ProprietaryName><NonProprietaryName>Benzonatate</NonProprietaryName></NDC><NDC><NDCCode>10631-094-20</NDCCode><ProprietaryName>Halog</ProprietaryName><NonProprietaryName>Halcinonide Cream</NonProprietaryName></NDC><NDC><NDCCode>10631-094-30</NDCCode><ProprietaryName>Halog</ProprietaryName><NonProprietaryName>Halcinonide Cream</NonProprietaryName></NDC><NDC><NDCCode>10631-094-71</NDCCode><ProprietaryName>Halog</ProprietaryName><NonProprietaryName>Halcinonide Cream</NonProprietaryName></NDC><NDC><NDCCode>10631-094-76</NDCCode><ProprietaryName>Halog</ProprietaryName><NonProprietaryName>Halcinonide Cream</NonProprietaryName></NDC><NDC><NDCCode>10812-094-01</NDCCode><ProprietaryName>Neutrogena Healthy Skin Compact Makeup</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>11090-094-01</NDCCode><ProprietaryName>It Cosmetics Your Skin But Better Cc Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum Spf 50 Plus Clear Sunscreen-deep Honey</ProprietaryName><NonProprietaryName>Homosalate, Octisalate And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>11489-094-01</NDCCode><ProprietaryName>Botanics Radiant Youth Protecting Day Cream Sunscreen Broad Spectrum Spf 15</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>11673-094-23</NDCCode><ProprietaryName>Up And Up Nasal Decongestant Pe</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11673-094-68</NDCCode><ProprietaryName>Up And Up Nasal Decongestant Pe</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11673-094-89</NDCCode><ProprietaryName>Up And Up Nasal Decongestant Pe</ProprietaryName><NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName></NDC></NDCList>