RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "76204-030-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-030-01)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL",
      "NDC11Code": "76204-0030-01",
      "ProductNDC": "76204-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Formoterol Fumarate Inhalation Solution",
      "NonProprietaryName": "Formoterol Fumarate Dihydrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216486",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "FORMOTEROL FUMARATE",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Formoterol Fumarate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1) .",
      "Description": "Formoterol Fumarate Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of Formoterol Fumarate Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta 2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is:. Formoterol fumarate dihydrate, USP has a molecular weight of 840.93 and its empirical formula is (C 19H 24N 2O 4) 2C 4H 4O 42H 2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol Fumarate Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus ®nebulizer (with a facemask or mouthpiece) connected to a PRONEB ®Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol Fumarate Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
    },
    {
      "NDCCode": "76204-030-02",
      "PackageDescription": "60 POUCH in 1 CARTON (76204-030-02)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL",
      "NDC11Code": "76204-0030-02",
      "ProductNDC": "76204-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Formoterol Fumarate Inhalation Solution",
      "NonProprietaryName": "Formoterol Fumarate Dihydrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250314",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216486",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "FORMOTEROL FUMARATE",
      "StrengthNumber": "20",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250314",
      "SamplePackage": "N",
      "IndicationAndUsage": "Formoterol Fumarate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1) .",
      "Description": "Formoterol Fumarate Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of Formoterol Fumarate Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta 2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is:. Formoterol fumarate dihydrate, USP has a molecular weight of 840.93 and its empirical formula is (C 19H 24N 2O 4) 2C 4H 4O 42H 2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol Fumarate Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus ®nebulizer (with a facemask or mouthpiece) connected to a PRONEB ®Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol Fumarate Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece."
    },
    {
      "NDCCode": "76204-010-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-010-01)  / 1 VIAL in 1 POUCH (76204-010-11)  / 3 mL in 1 VIAL",
      "NDC11Code": "76204-0010-01",
      "ProductNDC": "76204-010",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Albuterol Sulfate Inhalation Solution",
      "NonProprietaryName": "Albuterol Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214531",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "ALBUTEROL SULFATE",
      "StrengthNumber": ".63",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Albuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).",
      "Description": "Albuterol inhalation solution, USP is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2 - adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows:. The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (C 13 H 21NO 3) 2  H 2SO 4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol. Albuterol Inhalation Solution, USP is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride, edetate disodium (EDTA), and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution, EDTA is added as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol Inhalation Solution, USP does not require dilution prior to administration by nebulization. For Albuterol Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol Inhalation Solution, USP should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "76204-011-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-011-01)  / 1 VIAL in 1 POUCH (76204-011-11)  / 3 mL in 1 VIAL",
      "NDC11Code": "76204-0011-01",
      "ProductNDC": "76204-011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Albuterol Sulfate Inhalation Solution",
      "NonProprietaryName": "Albuterol Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20220104",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214531",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "ALBUTEROL SULFATE",
      "StrengthNumber": "1.25",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220104",
      "SamplePackage": "N",
      "IndicationAndUsage": "Albuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).",
      "Description": "Albuterol inhalation solution, USP is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2 - adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows:. The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (C 13 H 21NO 3) 2  H 2SO 4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol. Albuterol Inhalation Solution, USP is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride, edetate disodium (EDTA), and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution, EDTA is added as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol Inhalation Solution, USP does not require dilution prior to administration by nebulization. For Albuterol Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol Inhalation Solution, USP should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "76204-018-01",
      "PackageDescription": "1 POUCH in 1 CARTON (76204-018-01)  > 30 AMPULE in 1 POUCH (76204-018-11)  > 5 mL in 1 AMPULE",
      "NDC11Code": "76204-0018-01",
      "ProductNDC": "76204-018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Budesonide Inhalation Suspension",
      "NonProprietaryName": "Budesonide Inhalation Suspension",
      "DosageFormName": "SUSPENSION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20211201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210897",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "BUDESONIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20211201",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Maintenance Treatment of Asthma. Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: 1 Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.",
      "Description": "Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)- 11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C H O and its molecular weight is 430.5. Its structural formula is. Budesonide is white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10 3. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients anhydrous citric acid, disodium edetate dihydrate, polysorbate 80, sodium chloride, sodium citrate anhydrous and water for injection. It is available in single-dose ampules: 0.5 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)]."
    },
    {
      "NDCCode": "76204-026-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-026-01)  / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE",
      "NDC11Code": "76204-0026-01",
      "ProductNDC": "76204-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arformoterol Tartrate Inhalation Solution",
      "NonProprietaryName": "Arformoterol Tartrate Inhalation Solution",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20230227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214736",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "ARFORMOTEROL TARTRATE",
      "StrengthNumber": "15",
      "StrengthUnit": "ug/2mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230227",
      "SamplePackage": "N",
      "IndicationAndUsage": ". Arformoterol Tartrate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
      "Description": "Arformoterol Tartrate Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta 2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1­ methylethyl]amino]ethyl]phenyl]-,(2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows:. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C 19H 24N 2O 4●C 4H 6O 6 (1:1 salt). It is a white or off-white or light brown colored powder that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-­ tartrate. Arformoterol Tartrate Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 3 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. Arformoterol Tartrate Inhalation Solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC ® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol Tartrate Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information)."
    },
    {
      "NDCCode": "76204-027-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-027-01)  / 1 VIAL in 1 POUCH (76204-027-11)  / .5 mL in 1 VIAL",
      "NDC11Code": "76204-0027-01",
      "ProductNDC": "76204-027",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Albuterol Sulfate Inhalation Solution, 0.5%",
      "NonProprietaryName": "Albuterol Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20250324",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218386",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "ALBUTEROL SULFATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/.5mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250324",
      "SamplePackage": "N",
      "IndicationAndUsage": "Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.",
      "Description": "Albuterol Inhalation Solution, USP 0.5% contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2- adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1[(tert-Butylamino) methyl]-4-hydroxy-m-xylene-α, α’-diol sulfate (2:1) (salt), and the following chemical structure:. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol inhalation solution, USP 0.5%, is in concentrated form. Dilute 0.5 mL of the solution to 3 mL with sterile normal saline solution prior to administration. Each 0.5 mL Unit-Dose Vial Contains: 2.5 mg of albuterol (equivalent to 3 mg of albuterol sulfate, USP) in a sterile, aqueous solution; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Inhalation Solution, USP contains no sulfiting agents or preservatives. It is supplied in 0.5 mL sterile Unit-Dose Vials. Albuterol Inhalation Solution, USP is a clear, colorless to light yellow solution."
    },
    {
      "NDCCode": "76204-100-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-100-01)  / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE",
      "NDC11Code": "76204-0100-01",
      "ProductNDC": "76204-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ipratropium Bromide",
      "NonProprietaryName": "Ipratropium Bromide",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20110201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075693",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "IPRATROPIUM BROMIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/2.5mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20111121",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.",
      "Description": "The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate  C 20H 30BrNO 3H 2O  Mol.Wt. 430.4. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid."
    },
    {
      "NDCCode": "76204-200-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-200-01)  / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE",
      "NDC11Code": "76204-0200-01",
      "ProductNDC": "76204-200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Albuterol Sulfate",
      "NonProprietaryName": "Albuterol Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20111205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077839",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "ALBUTEROL SULFATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20111205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.",
      "Description": "Albuterol inhalation solution is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α 1-[( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula:. Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C 13H 21NO 3) 2  H 2SO 4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol inhalation solution 0.083% requires no dilution before administration. Each milliliter of Albuterol Inhalation Solution, USP 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Inhalation Solution, USP 0.083% contains no sulfiting agents or preservatives. Albuterol inhalation solution is a clear, colorless to light yellow solution."
    },
    {
      "NDCCode": "76204-600-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-600-01)  / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE",
      "NDC11Code": "76204-0600-01",
      "ProductNDC": "76204-600",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
      "NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20121015",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202496",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "ALBUTEROL SULFATE; IPRATROPIUM BROMIDE",
      "StrengthNumber": "2.5; .5",
      "StrengthUnit": "mg/3mL; mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20121015",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
      "Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "76204-700-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-700-01)  / 1 AMPULE in 1 POUCH (76204-700-11)  / 3 mL in 1 AMPULE",
      "NDC11Code": "76204-0700-01",
      "ProductNDC": "76204-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levalbuterol",
      "NonProprietaryName": "Levalbuterol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203653",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
      "StrengthNumber": ".31",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170217",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
      "Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C 13H 21NO 3∙HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
    },
    {
      "NDCCode": "76204-800-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-800-01)  / 1 AMPULE in 1 POUCH (76204-800-11)  / 3 mL in 1 AMPULE",
      "NDC11Code": "76204-0800-01",
      "ProductNDC": "76204-800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levalbuterol",
      "NonProprietaryName": "Levalbuterol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203653",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
      "StrengthNumber": ".63",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170217",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
      "Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C 13H 21NO 3∙HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
    },
    {
      "NDCCode": "76204-900-01",
      "PackageDescription": "30 POUCH in 1 CARTON (76204-900-01)  / 1 AMPULE in 1 POUCH (76204-900-11)  / 3 mL in 1 AMPULE",
      "NDC11Code": "76204-0900-01",
      "ProductNDC": "76204-900",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levalbuterol",
      "NonProprietaryName": "Levalbuterol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203653",
      "LabelerName": "Ritedose Pharmaceuticals, LLC",
      "SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
      "StrengthNumber": "1.25",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170217",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
      "Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C 13H 21NO 3∙HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
    },
    {
      "NDCCode": "10028-030-02",
      "PackageDescription": "1 CARTON in 1 CARTON (10028-030-02)  / 75 mL in 1 CARTON (10028-030-01) ",
      "NDC11Code": "10028-0030-02",
      "ProductNDC": "10028-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ultra Uv Protective Daily Moisturising Spf 30 Mineral Sunscreen",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250605",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Ultraceuticals Pty Ltd",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "14",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-10-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250605",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11054-030-01",
      "PackageDescription": "425 L in 1 CYLINDER (11054-030-01)",
      "NDC11Code": "11054-0030-01",
      "ProductNDC": "11054-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbon Dioxide, Air",
      "NonProprietaryName": "Carbon Dioxide, Air",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19971014",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "AIRGAS USA, LLC",
      "SubstanceName": "AIR; CARBON DIOXIDE",
      "StrengthNumber": "800; 200",
      "StrengthUnit": "mL/L; mL/L",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2014-04-03"
    },
    {
      "NDCCode": "11086-047-01",
      "PackageDescription": "1 KIT in 1 BOX (11086-047-01)  *  160 mL in 1 BOTTLE, WITH APPLICATOR (11086-043-06)  *  60 g in 1 BOTTLE, WITH APPLICATOR (11086-030-60) ",
      "NDC11Code": "11086-0047-01",
      "ProductNDC": "11086-047",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Keralyt",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20091101",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "SUMMERS LABORATORIES INC",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091101",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS AND USAGE- For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.",
      "Description": "DESCRIPTION:KERALYT ®is a gel for topical administration containing salicylic acid 6%, in a vehicle composed of propylene glycol, SD-40 alcohol (21%), hydroxypropylcellulose and purified water. Salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure:."
    },
    {
      "NDCCode": "11559-030-01",
      "PackageDescription": "1 TUBE in 1 CARTON (11559-030-01)  / 30 mL in 1 TUBE",
      "NDC11Code": "11559-0030-01",
      "ProductNDC": "11559-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Double Wear Maximum Cover Camouflage Makeup For Face And Body Broad Spectrum Spf 15",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "ESTEE LAUDER INC",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "14",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20101001",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn."
    },
    {
      "NDCCode": "13668-030-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (13668-030-01) ",
      "NDC11Code": "13668-0030-01",
      "ProductNDC": "13668-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100415",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079191",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20100415",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "13733-030-01",
      "PackageDescription": "40 mL in 1 CARTON (13733-030-01)",
      "NDC11Code": "13733-0030-01",
      "ProductNDC": "13733-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Missha All Around Safe Block Soft Finish Sun Milk",
      "ProprietaryNameSuffix": "Broad Spectrum Spf 50 Plus",
      "NonProprietaryName": "Octinoxate, Zinc Oxide, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130301",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "ABLE C&C CO., LTD.",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE",
      "StrengthNumber": "3; 2.76; .87",
      "StrengthUnit": "mg/40mL; mg/40mL; mg/40mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-01-08",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "14141-030-01",
      "PackageDescription": "1 TUBE in 1 BOX (14141-030-01)  / 30 g in 1 TUBE",
      "NDC11Code": "14141-0030-01",
      "ProductNDC": "14141-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Almendra 230-n",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220413",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "BEL STAR S A",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": "40; 24",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-02-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "14335-030-01",
      "PackageDescription": "10 VIAL in 1 CARTON (14335-030-01)  > 10 mL in 1 VIAL",
      "NDC11Code": "14335-0030-01",
      "ProductNDC": "14335-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ganciclovir",
      "NonProprietaryName": "Ganciclovir Sodium",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENTRICULAR",
      "StartMarketingDate": "20190211",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204204",
      "LabelerName": "Hainan Poly Pharm. Co., Ltd.",
      "SubstanceName": "GANCICLOVIR SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ganciclovir for Injection, USP is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: 1 treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1) , 2 prevention of CMV disease in adult transplant recipients at risk for CMV disease. (  1.2)  .",
      "Description": "Ganciclovir for injection contains ganciclovir, in the form of the sodium salt for intravenous injection. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). Chemically, ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine and ganciclovir sodium is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The chemical structures of ganciclovir sodium and ganciclovir are. Ganciclovir is a white to off-white crystalline powder. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.022. The pK as for ganciclovir are 2.2 and 9.4. Ganciclovir for injection (ganciclovir), formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to off-white lyophilized powder. The lyophilized powder has an aqueous solubility of greater than 50 mg/mL at 25°C. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37°C. Each vial contains ganciclovir sodium equivalent to 500 mg ganciclovir. Inactive ingredients may include hydrochloric acid (QS) and sodium hydroxide (QS) added to adjust the pH. All doses in this package insert are specified in terms of ganciclovir."
    },
    {
      "NDCCode": "14474-030-01",
      "PackageDescription": "25 kg in 1 CONTAINER (14474-030-01)",
      "NDC11Code": "14474-0030-01",
      "ProductNDC": "14474-030",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Alcaftadine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20121001",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Sai Life Sciences Limited",
      "SubstanceName": "ALCAFTADINE",
      "StrengthNumber": "25",
      "StrengthUnit": "kg/25kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "14783-030-02",
      "PackageDescription": "1 CARTRIDGE in 1 BOX (14783-030-02)  > 10 g in 1 CARTRIDGE (14783-030-01)",
      "NDC11Code": "14783-0030-02",
      "ProductNDC": "14783-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel",
      "ProprietaryNameSuffix": "Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Plateado/double Use Compact Spf 15 Silver Deluxe Edition Claire 4",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide, And Octinoxate",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130527",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura International LTD.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE",
      "StrengthNumber": ".062393; .049; .03",
      "StrengthUnit": "g/g; g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "NDCCode": "16714-030-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (16714-030-01)  / 118 mL in 1 BOTTLE",
      "NDC11Code": "16714-0030-01",
      "ProductNDC": "16714-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210328",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214867",
      "LabelerName": "NORTHSTAR RX LLC",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210328",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older ( 1). Limitations of Use: 1 Do not use on the face, axillae or groin. ( 1.2) , 2 Avoid any contact with the eyes and lips. ( 1.2) .",
      "Description": "Clobetasol Propionate Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of Clobetasol Propionate Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol (95% v/v), citric acid monohydrate, coco-betaine, polyquaternium-10, purified water, sodium citrate dihydrate, and sodium laureth-2 sulfate."
    },
    {
      "NDCCode": "16729-030-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (16729-030-01) ",
      "NDC11Code": "16729-0030-01",
      "ProductNDC": "16729-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methyldopa",
      "NonProprietaryName": "Methyldopa",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120724",
      "EndMarketingDate": "20220831",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070084",
      "LabelerName": "Accord Healthcare Inc.",
      "SubstanceName": "METHYLDOPA",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120724",
      "EndMarketingDatePackage": "20220831",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "17518-030-01",
      "PackageDescription": "240 PACKET in 1 CASE (17518-030-01)  / .0000273 L in 1 PACKET",
      "NDC11Code": "17518-0030-01",
      "ProductNDC": "17518-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "3m Cavilon Durable Barrier",
      "NonProprietaryName": "Dimethicone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160601",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Solventum US LLC",
      "SubstanceName": "DIMETHICONE",
      "StrengthNumber": "13000",
      "StrengthUnit": "mg/L",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily protects and helps relieve chapped or cracked skin."
    },
    {
      "NDCCode": "19339-030-01",
      "PackageDescription": "300 mL in 1 BOTTLE, SPRAY (19339-030-01) ",
      "NDC11Code": "19339-0030-01",
      "ProductNDC": "19339-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Esco Fresh Pure Mist",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Arca Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "210",
      "StrengthUnit": "mL/300mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses:Disinfection of hands and skin."
    },
    {
      "NDCCode": "22700-030-01",
      "PackageDescription": "1 BOTTLE in 1 CARTON (22700-030-01)  / 30 mL in 1 BOTTLE",
      "NDC11Code": "22700-0030-01",
      "ProductNDC": "22700-030",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 Hr Full Coverage Spf 18 Octinoxate Sunscreen Liquid Foundation",
      "NonProprietaryName": "Octinoxate",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20211201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Noxell Corporation",
      "SubstanceName": "OCTINOXATE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211201",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures."
    },
    {
      "NDCCode": "23155-030-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (23155-030-01) ",
      "NDC11Code": "23155-0030-01",
      "ProductNDC": "23155-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine",
      "NonProprietaryName": "Fluoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241013",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201336",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241013",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluoxetine Capsules are indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]., 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]., 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]., 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].",
      "Description": "Fluoxetine Capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain gelatin, iron oxide yellow, magnesium stearate, pregelatinized starch, titanium dioxide, and other inactive ingredients. The 10 and 20 mg capsules also contain FD&C Blue No. 1, and the 40 mg capsule also contains FD&C Blue No. 1 and FD&C Yellow No. 6. The imprinting ink contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze."
    },
    {
      "NDCCode": "24724-030-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (24724-030-01)",
      "NDC11Code": "24724-0030-01",
      "ProductNDC": "24724-030",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Letrozole",
      "NonProprietaryName": "Letrozole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110615",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201804",
      "LabelerName": "INDICUS PHARMA LLC",
      "SubstanceName": "LETROZOLE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Letrozole tablets are an aromatase inhibitor indicated for: : 1 Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (1.1), 2 Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (1.2), 3 First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (1.3) .",
      "Description": "Letrozole tablets for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula is. Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C17H11N5, and a melting range of 184°C-185°C. Letrozole tablets are available as 2.5 mg tablets film-coated for oral administration. Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, pre-gelatinized starch, colloidal silicon dioxide, magnesium stearate, purified water and hypromellose 2910 6cP, titanium dioxide and PEG 400."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"76204-030-01","ProprietaryName":"Formoterol Fumarate Inhalation Solution","NonProprietaryName":"Formoterol Fumarate Dihydrate"},{"NDCCode":"76204-030-02","ProprietaryName":"Formoterol Fumarate Inhalation Solution","NonProprietaryName":"Formoterol Fumarate Dihydrate"},{"NDCCode":"76204-010-01","ProprietaryName":"Albuterol Sulfate Inhalation Solution","NonProprietaryName":"Albuterol Sulfate"},{"NDCCode":"76204-011-01","ProprietaryName":"Albuterol Sulfate Inhalation Solution","NonProprietaryName":"Albuterol Sulfate"},{"NDCCode":"76204-018-01","ProprietaryName":"Budesonide Inhalation Suspension","NonProprietaryName":"Budesonide Inhalation Suspension"},{"NDCCode":"76204-026-01","ProprietaryName":"Arformoterol Tartrate Inhalation Solution","NonProprietaryName":"Arformoterol Tartrate Inhalation Solution"},{"NDCCode":"76204-027-01","ProprietaryName":"Albuterol Sulfate Inhalation Solution, 0.5%","NonProprietaryName":"Albuterol Sulfate"},{"NDCCode":"76204-100-01","ProprietaryName":"Ipratropium Bromide","NonProprietaryName":"Ipratropium Bromide"},{"NDCCode":"76204-200-01","ProprietaryName":"Albuterol Sulfate","NonProprietaryName":"Albuterol Sulfate"},{"NDCCode":"76204-600-01","ProprietaryName":"Ipratropium Bromide And Albuterol Sulfate","NonProprietaryName":"Ipratropium Bromide And Albuterol Sulfate"},{"NDCCode":"76204-700-01","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"76204-800-01","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"76204-900-01","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"10028-030-02","ProprietaryName":"Ultra Uv Protective Daily Moisturising Spf 30 Mineral Sunscreen","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"11054-030-01","ProprietaryName":"Carbon Dioxide, Air","NonProprietaryName":"Carbon Dioxide, Air"},{"NDCCode":"11086-047-01","ProprietaryName":"Keralyt","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"11559-030-01","ProprietaryName":"Double Wear Maximum Cover Camouflage Makeup For Face And Body Broad Spectrum Spf 15","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"13668-030-01","ProprietaryName":"Cetirizine Hydrochloride","NonProprietaryName":"Cetirizine Hydrochloride"},{"NDCCode":"13733-030-01","ProprietaryName":"Missha All Around Safe Block Soft Finish Sun Milk","NonProprietaryName":"Octinoxate, Zinc Oxide, Titanium Dioxide"},{"NDCCode":"14141-030-01","ProprietaryName":"Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Almendra 230-n","NonProprietaryName":"Octinoxate, Zinc Oxide"},{"NDCCode":"14335-030-01","ProprietaryName":"Ganciclovir","NonProprietaryName":"Ganciclovir Sodium"},{"NDCCode":"14474-030-01","NonProprietaryName":"Alcaftadine"},{"NDCCode":"14783-030-02","ProprietaryName":"Lbel","NonProprietaryName":"Titanium Dioxide, Zinc Oxide, And Octinoxate"},{"NDCCode":"16714-030-01","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate"},{"NDCCode":"16729-030-01","ProprietaryName":"Methyldopa","NonProprietaryName":"Methyldopa"},{"NDCCode":"17518-030-01","ProprietaryName":"3m Cavilon Durable Barrier","NonProprietaryName":"Dimethicone"},{"NDCCode":"19339-030-01","ProprietaryName":"Esco Fresh Pure Mist","NonProprietaryName":"Alcohol"},{"NDCCode":"22700-030-01","ProprietaryName":"Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 Hr Full Coverage Spf 18 Octinoxate Sunscreen Liquid Foundation","NonProprietaryName":"Octinoxate"},{"NDCCode":"23155-030-01","ProprietaryName":"Fluoxetine","NonProprietaryName":"Fluoxetine"},{"NDCCode":"24724-030-01","ProprietaryName":"Letrozole","NonProprietaryName":"Letrozole"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>76204-030-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-030-01)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>76204-0030-01</NDC11Code>
    <ProductNDC>76204-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Formoterol Fumarate Inhalation Solution</ProprietaryName>
    <NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216486</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>ug/2mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Formoterol Fumarate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1) .</IndicationAndUsage>
    <Description>Formoterol Fumarate Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of Formoterol Fumarate Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta 2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is:. Formoterol fumarate dihydrate, USP has a molecular weight of 840.93 and its empirical formula is (C 19H 24N 2O 4) 2C 4H 4O 42H 2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol Fumarate Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus ®nebulizer (with a facemask or mouthpiece) connected to a PRONEB ®Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol Fumarate Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-030-02</NDCCode>
    <PackageDescription>60 POUCH in 1 CARTON (76204-030-02)  / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL</PackageDescription>
    <NDC11Code>76204-0030-02</NDC11Code>
    <ProductNDC>76204-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Formoterol Fumarate Inhalation Solution</ProprietaryName>
    <NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216486</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>FORMOTEROL FUMARATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>ug/2mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Formoterol Fumarate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1) .</IndicationAndUsage>
    <Description>Formoterol Fumarate Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of Formoterol Fumarate Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta 2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is:. Formoterol fumarate dihydrate, USP has a molecular weight of 840.93 and its empirical formula is (C 19H 24N 2O 4) 2C 4H 4O 42H 2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol Fumarate Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus ®nebulizer (with a facemask or mouthpiece) connected to a PRONEB ®Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol Fumarate Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-010-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-010-01)  / 1 VIAL in 1 POUCH (76204-010-11)  / 3 mL in 1 VIAL</PackageDescription>
    <NDC11Code>76204-0010-01</NDC11Code>
    <ProductNDC>76204-010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate Inhalation Solution</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20220104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214531</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>.63</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).</IndicationAndUsage>
    <Description>Albuterol inhalation solution, USP is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2 - adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows:. The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (C 13 H 21NO 3) 2  H 2SO 4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol. Albuterol Inhalation Solution, USP is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride, edetate disodium (EDTA), and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution, EDTA is added as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol Inhalation Solution, USP does not require dilution prior to administration by nebulization. For Albuterol Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol Inhalation Solution, USP should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-011-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-011-01)  / 1 VIAL in 1 POUCH (76204-011-11)  / 3 mL in 1 VIAL</PackageDescription>
    <NDC11Code>76204-0011-01</NDC11Code>
    <ProductNDC>76204-011</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate Inhalation Solution</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20220104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214531</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>1.25</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220104</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).</IndicationAndUsage>
    <Description>Albuterol inhalation solution, USP is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2 - adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows:. The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (C 13 H 21NO 3) 2  H 2SO 4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol. Albuterol Inhalation Solution, USP is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride, edetate disodium (EDTA), and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution, EDTA is added as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol Inhalation Solution, USP does not require dilution prior to administration by nebulization. For Albuterol Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol Inhalation Solution, USP should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-018-01</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (76204-018-01)  &gt; 30 AMPULE in 1 POUCH (76204-018-11)  &gt; 5 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>76204-0018-01</NDC11Code>
    <ProductNDC>76204-018</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Budesonide Inhalation Suspension</ProprietaryName>
    <NonProprietaryName>Budesonide Inhalation Suspension</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20211201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210897</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>BUDESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.1 Maintenance Treatment of Asthma. Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: 1 Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.</IndicationAndUsage>
    <Description>Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)- 11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C H O and its molecular weight is 430.5. Its structural formula is. Budesonide is white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10 3. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients anhydrous citric acid, disodium edetate dihydrate, polysorbate 80, sodium chloride, sodium citrate anhydrous and water for injection. It is available in single-dose ampules: 0.5 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-026-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-026-01)  / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>76204-0026-01</NDC11Code>
    <ProductNDC>76204-026</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Arformoterol Tartrate Inhalation Solution</ProprietaryName>
    <NonProprietaryName>Arformoterol Tartrate Inhalation Solution</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20230227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214736</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>ug/2mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>. Arformoterol Tartrate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for: : 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
    <Description>Arformoterol Tartrate Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta 2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1­ methylethyl]amino]ethyl]phenyl]-,(2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows:. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C 19H 24N 2O 4●C 4H 6O 6 (1:1 salt). It is a white or off-white or light brown colored powder that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-­ tartrate. Arformoterol Tartrate Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 3 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. Arformoterol Tartrate Inhalation Solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC ® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. Arformoterol Tartrate Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information).</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-027-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-027-01)  / 1 VIAL in 1 POUCH (76204-027-11)  / .5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>76204-0027-01</NDC11Code>
    <ProductNDC>76204-027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate Inhalation Solution, 0.5%</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20250324</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218386</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250324</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.</IndicationAndUsage>
    <Description>Albuterol Inhalation Solution, USP 0.5% contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2- adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1[(tert-Butylamino) methyl]-4-hydroxy-m-xylene-α, α’-diol sulfate (2:1) (salt), and the following chemical structure:. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol inhalation solution, USP 0.5%, is in concentrated form. Dilute 0.5 mL of the solution to 3 mL with sterile normal saline solution prior to administration. Each 0.5 mL Unit-Dose Vial Contains: 2.5 mg of albuterol (equivalent to 3 mg of albuterol sulfate, USP) in a sterile, aqueous solution; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Inhalation Solution, USP contains no sulfiting agents or preservatives. It is supplied in 0.5 mL sterile Unit-Dose Vials. Albuterol Inhalation Solution, USP is a clear, colorless to light yellow solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-100-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-100-01)  / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>76204-0100-01</NDC11Code>
    <ProductNDC>76204-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ipratropium Bromide</ProprietaryName>
    <NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20110201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075693</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/2.5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.</IndicationAndUsage>
    <Description>The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate  C 20H 30BrNO 3H 2O  Mol.Wt. 430.4. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-200-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-200-01)  / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>76204-0200-01</NDC11Code>
    <ProductNDC>76204-200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20111205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077839</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20111205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.</IndicationAndUsage>
    <Description>Albuterol inhalation solution is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α 1-[( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula:. Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C 13H 21NO 3) 2  H 2SO 4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol inhalation solution 0.083% requires no dilution before administration. Each milliliter of Albuterol Inhalation Solution, USP 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Inhalation Solution, USP 0.083% contains no sulfiting agents or preservatives. Albuterol inhalation solution is a clear, colorless to light yellow solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-600-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-600-01)  / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>76204-0600-01</NDC11Code>
    <ProductNDC>76204-600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20121015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202496</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE; IPRATROPIUM BROMIDE</SubstanceName>
    <StrengthNumber>2.5; .5</StrengthNumber>
    <StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
    <Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).</Description>
  </NDC>
  <NDC>
    <NDCCode>76204-700-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-700-01)  / 1 AMPULE in 1 POUCH (76204-700-11)  / 3 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>76204-0700-01</NDC11Code>
    <ProductNDC>76204-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levalbuterol</ProprietaryName>
    <NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203653</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.31</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
    <Description>Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C 13H 21NO 3∙HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
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  <NDC>
    <NDCCode>76204-800-01</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (76204-800-01)  / 1 AMPULE in 1 POUCH (76204-800-11)  / 3 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>76204-0800-01</NDC11Code>
    <ProductNDC>76204-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
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    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203653</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.63</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
    <Description>Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C 13H 21NO 3∙HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
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  <NDC>
    <NDCCode>76204-900-01</NDCCode>
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    <ProductNDC>76204-900</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levalbuterol</ProprietaryName>
    <NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203653</ApplicationNumber>
    <LabelerName>Ritedose Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.25</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
    <Description>Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C 13H 21NO 3∙HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
  </NDC>
  <NDC>
    <NDCCode>10028-030-02</NDCCode>
    <PackageDescription>1 CARTON in 1 CARTON (10028-030-02)  / 75 mL in 1 CARTON (10028-030-01) </PackageDescription>
    <NDC11Code>10028-0030-02</NDC11Code>
    <ProductNDC>10028-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ultra Uv Protective Daily Moisturising Spf 30 Mineral Sunscreen</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250605</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Ultraceuticals Pty Ltd</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-10-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>11054-030-01</NDCCode>
    <PackageDescription>425 L in 1 CYLINDER (11054-030-01)</PackageDescription>
    <NDC11Code>11054-0030-01</NDC11Code>
    <ProductNDC>11054-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbon Dioxide, Air</ProprietaryName>
    <NonProprietaryName>Carbon Dioxide, Air</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19971014</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>AIRGAS USA, LLC</LabelerName>
    <SubstanceName>AIR; CARBON DIOXIDE</SubstanceName>
    <StrengthNumber>800; 200</StrengthNumber>
    <StrengthUnit>mL/L; mL/L</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-04-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>11086-047-01</NDCCode>
    <PackageDescription>1 KIT in 1 BOX (11086-047-01)  *  160 mL in 1 BOTTLE, WITH APPLICATOR (11086-043-06)  *  60 g in 1 BOTTLE, WITH APPLICATOR (11086-030-60) </PackageDescription>
    <NDC11Code>11086-0047-01</NDC11Code>
    <ProductNDC>11086-047</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Keralyt</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20091101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>SUMMERS LABORATORIES INC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS AND USAGE- For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.</IndicationAndUsage>
    <Description>DESCRIPTION:KERALYT ®is a gel for topical administration containing salicylic acid 6%, in a vehicle composed of propylene glycol, SD-40 alcohol (21%), hydroxypropylcellulose and purified water. Salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure:.</Description>
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  <NDC>
    <NDCCode>11559-030-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (11559-030-01)  / 30 mL in 1 TUBE</PackageDescription>
    <NDC11Code>11559-0030-01</NDC11Code>
    <ProductNDC>11559-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Double Wear Maximum Cover Camouflage Makeup For Face And Body Broad Spectrum Spf 15</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ESTEE LAUDER INC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
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  <NDC>
    <NDCCode>13668-030-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (13668-030-01) </PackageDescription>
    <NDC11Code>13668-0030-01</NDC11Code>
    <ProductNDC>13668-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079191</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>13733-030-01</NDCCode>
    <PackageDescription>40 mL in 1 CARTON (13733-030-01)</PackageDescription>
    <NDC11Code>13733-0030-01</NDC11Code>
    <ProductNDC>13733-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Missha All Around Safe Block Soft Finish Sun Milk</ProprietaryName>
    <ProprietaryNameSuffix>Broad Spectrum Spf 50 Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Zinc Oxide, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ABLE C&amp;C CO., LTD.</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>3; 2.76; .87</StrengthNumber>
    <StrengthUnit>mg/40mL; mg/40mL; mg/40mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-01-08</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>14141-030-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (14141-030-01)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>14141-0030-01</NDC11Code>
    <ProductNDC>14141-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Almendra 230-n</ProprietaryName>
    <NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220413</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>BEL STAR S A</LabelerName>
    <SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>40; 24</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>14335-030-01</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (14335-030-01)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>14335-0030-01</NDC11Code>
    <ProductNDC>14335-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ganciclovir</ProprietaryName>
    <NonProprietaryName>Ganciclovir Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENTRICULAR</RouteName>
    <StartMarketingDate>20190211</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204204</ApplicationNumber>
    <LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
    <SubstanceName>GANCICLOVIR SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ganciclovir for Injection, USP is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: 1 treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1) , 2 prevention of CMV disease in adult transplant recipients at risk for CMV disease. (  1.2)  .</IndicationAndUsage>
    <Description>Ganciclovir for injection contains ganciclovir, in the form of the sodium salt for intravenous injection. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). Chemically, ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine and ganciclovir sodium is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The chemical structures of ganciclovir sodium and ganciclovir are. Ganciclovir is a white to off-white crystalline powder. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.022. The pK as for ganciclovir are 2.2 and 9.4. Ganciclovir for injection (ganciclovir), formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to off-white lyophilized powder. The lyophilized powder has an aqueous solubility of greater than 50 mg/mL at 25°C. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37°C. Each vial contains ganciclovir sodium equivalent to 500 mg ganciclovir. Inactive ingredients may include hydrochloric acid (QS) and sodium hydroxide (QS) added to adjust the pH. All doses in this package insert are specified in terms of ganciclovir.</Description>
  </NDC>
  <NDC>
    <NDCCode>14474-030-01</NDCCode>
    <PackageDescription>25 kg in 1 CONTAINER (14474-030-01)</PackageDescription>
    <NDC11Code>14474-0030-01</NDC11Code>
    <ProductNDC>14474-030</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Alcaftadine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20121001</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Sai Life Sciences Limited</LabelerName>
    <SubstanceName>ALCAFTADINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>kg/25kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>14783-030-02</NDCCode>
    <PackageDescription>1 CARTRIDGE in 1 BOX (14783-030-02)  &gt; 10 g in 1 CARTRIDGE (14783-030-01)</PackageDescription>
    <NDC11Code>14783-0030-02</NDC11Code>
    <ProductNDC>14783-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lbel</ProprietaryName>
    <ProprietaryNameSuffix>Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Plateado/double Use Compact Spf 15 Silver Deluxe Edition Claire 4</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide, And Octinoxate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130527</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ventura International LTD.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>.062393; .049; .03</StrengthNumber>
    <StrengthUnit>g/g; g/g; g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-030-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (16714-030-01)  / 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>16714-0030-01</NDC11Code>
    <ProductNDC>16714-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210328</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214867</ApplicationNumber>
    <LabelerName>NORTHSTAR RX LLC</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210328</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older ( 1). Limitations of Use: 1 Do not use on the face, axillae or groin. ( 1.2) , 2 Avoid any contact with the eyes and lips. ( 1.2) .</IndicationAndUsage>
    <Description>Clobetasol Propionate Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25H 32CIFO 5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of Clobetasol Propionate Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol (95% v/v), citric acid monohydrate, coco-betaine, polyquaternium-10, purified water, sodium citrate dihydrate, and sodium laureth-2 sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-030-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16729-030-01) </PackageDescription>
    <NDC11Code>16729-0030-01</NDC11Code>
    <ProductNDC>16729-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methyldopa</ProprietaryName>
    <NonProprietaryName>Methyldopa</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120724</StartMarketingDate>
    <EndMarketingDate>20220831</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070084</ApplicationNumber>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>METHYLDOPA</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120724</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>17518-030-01</NDCCode>
    <PackageDescription>240 PACKET in 1 CASE (17518-030-01)  / .0000273 L in 1 PACKET</PackageDescription>
    <NDC11Code>17518-0030-01</NDC11Code>
    <ProductNDC>17518-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>3m Cavilon Durable Barrier</ProprietaryName>
    <NonProprietaryName>Dimethicone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Solventum US LLC</LabelerName>
    <SubstanceName>DIMETHICONE</SubstanceName>
    <StrengthNumber>13000</StrengthNumber>
    <StrengthUnit>mg/L</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily protects and helps relieve chapped or cracked skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>19339-030-01</NDCCode>
    <PackageDescription>300 mL in 1 BOTTLE, SPRAY (19339-030-01) </PackageDescription>
    <NDC11Code>19339-0030-01</NDC11Code>
    <ProductNDC>19339-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Esco Fresh Pure Mist</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Arca Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>210</StrengthNumber>
    <StrengthUnit>mL/300mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses:Disinfection of hands and skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>22700-030-01</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (22700-030-01)  / 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>22700-0030-01</NDC11Code>
    <ProductNDC>22700-030</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 Hr Full Coverage Spf 18 Octinoxate Sunscreen Liquid Foundation</ProprietaryName>
    <NonProprietaryName>Octinoxate</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20211201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Noxell Corporation</LabelerName>
    <SubstanceName>OCTINOXATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-11-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>23155-030-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (23155-030-01) </PackageDescription>
    <NDC11Code>23155-0030-01</NDC11Code>
    <ProductNDC>23155-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241013</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201336</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine Capsules are indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]., 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]., 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]., 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Fluoxetine Capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain gelatin, iron oxide yellow, magnesium stearate, pregelatinized starch, titanium dioxide, and other inactive ingredients. The 10 and 20 mg capsules also contain FD&amp;C Blue No. 1, and the 40 mg capsule also contains FD&amp;C Blue No. 1 and FD&amp;C Yellow No. 6. The imprinting ink contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>24724-030-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (24724-030-01)</PackageDescription>
    <NDC11Code>24724-0030-01</NDC11Code>
    <ProductNDC>24724-030</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Letrozole</ProprietaryName>
    <NonProprietaryName>Letrozole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110615</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201804</ApplicationNumber>
    <LabelerName>INDICUS PHARMA LLC</LabelerName>
    <SubstanceName>LETROZOLE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Letrozole tablets are an aromatase inhibitor indicated for: : 1 Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (1.1), 2 Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (1.2), 3 First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (1.3) .</IndicationAndUsage>
    <Description>Letrozole tablets for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula is. Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C17H11N5, and a melting range of 184°C-185°C. Letrozole tablets are available as 2.5 mg tablets film-coated for oral administration. Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, pre-gelatinized starch, colloidal silicon dioxide, magnesium stearate, purified water and hypromellose 2910 6cP, titanium dioxide and PEG 400.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>76204-030-01</NDCCode><ProprietaryName>Formoterol Fumarate Inhalation Solution</ProprietaryName><NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>76204-030-02</NDCCode><ProprietaryName>Formoterol Fumarate Inhalation Solution</ProprietaryName><NonProprietaryName>Formoterol Fumarate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>76204-010-01</NDCCode><ProprietaryName>Albuterol Sulfate Inhalation Solution</ProprietaryName><NonProprietaryName>Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>76204-011-01</NDCCode><ProprietaryName>Albuterol Sulfate Inhalation Solution</ProprietaryName><NonProprietaryName>Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>76204-018-01</NDCCode><ProprietaryName>Budesonide Inhalation Suspension</ProprietaryName><NonProprietaryName>Budesonide Inhalation Suspension</NonProprietaryName></NDC><NDC><NDCCode>76204-026-01</NDCCode><ProprietaryName>Arformoterol Tartrate Inhalation Solution</ProprietaryName><NonProprietaryName>Arformoterol Tartrate Inhalation Solution</NonProprietaryName></NDC><NDC><NDCCode>76204-027-01</NDCCode><ProprietaryName>Albuterol Sulfate Inhalation Solution, 0.5%</ProprietaryName><NonProprietaryName>Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>76204-100-01</NDCCode><ProprietaryName>Ipratropium Bromide</ProprietaryName><NonProprietaryName>Ipratropium Bromide</NonProprietaryName></NDC><NDC><NDCCode>76204-200-01</NDCCode><ProprietaryName>Albuterol Sulfate</ProprietaryName><NonProprietaryName>Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>76204-600-01</NDCCode><ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName><NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>76204-700-01</NDCCode><ProprietaryName>Levalbuterol</ProprietaryName><NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76204-800-01</NDCCode><ProprietaryName>Levalbuterol</ProprietaryName><NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76204-900-01</NDCCode><ProprietaryName>Levalbuterol</ProprietaryName><NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10028-030-02</NDCCode><ProprietaryName>Ultra Uv Protective Daily Moisturising Spf 30 Mineral Sunscreen</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>11054-030-01</NDCCode><ProprietaryName>Carbon Dioxide, Air</ProprietaryName><NonProprietaryName>Carbon Dioxide, Air</NonProprietaryName></NDC><NDC><NDCCode>11086-047-01</NDCCode><ProprietaryName>Keralyt</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>11559-030-01</NDCCode><ProprietaryName>Double Wear Maximum Cover Camouflage Makeup For Face And Body Broad Spectrum Spf 15</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>13668-030-01</NDCCode><ProprietaryName>Cetirizine Hydrochloride</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>13733-030-01</NDCCode><ProprietaryName>Missha All Around Safe Block Soft Finish Sun Milk</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>14141-030-01</NDCCode><ProprietaryName>Cyzone Studio Look Base De Alta Cobertura Y Larga Duracion Fps 20 Almendra 230-n</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>14335-030-01</NDCCode><ProprietaryName>Ganciclovir</ProprietaryName><NonProprietaryName>Ganciclovir Sodium</NonProprietaryName></NDC><NDC><NDCCode>14474-030-01</NDCCode><NonProprietaryName>Alcaftadine</NonProprietaryName></NDC><NDC><NDCCode>14783-030-02</NDCCode><ProprietaryName>Lbel</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide, And Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>16714-030-01</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>16729-030-01</NDCCode><ProprietaryName>Methyldopa</ProprietaryName><NonProprietaryName>Methyldopa</NonProprietaryName></NDC><NDC><NDCCode>17518-030-01</NDCCode><ProprietaryName>3m Cavilon Durable Barrier</ProprietaryName><NonProprietaryName>Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>19339-030-01</NDCCode><ProprietaryName>Esco Fresh Pure Mist</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>22700-030-01</NDCCode><ProprietaryName>Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 Hr Full Coverage Spf 18 Octinoxate Sunscreen Liquid Foundation</ProprietaryName><NonProprietaryName>Octinoxate</NonProprietaryName></NDC><NDC><NDCCode>23155-030-01</NDCCode><ProprietaryName>Fluoxetine</ProprietaryName><NonProprietaryName>Fluoxetine</NonProprietaryName></NDC><NDC><NDCCode>24724-030-01</NDCCode><ProprietaryName>Letrozole</ProprietaryName><NonProprietaryName>Letrozole</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
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      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
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    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
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      "FirstLineMailingAddress": "2821 SW 28TH ST",
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      "MailingAddressCountryCode": "US",
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      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
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      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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