RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "62670-4815-0",
      "PackageDescription": "29 mL in 1 BOTTLE (62670-4815-0)",
      "NDC11Code": "62670-4815-00",
      "ProductNDC": "62670-4815",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-bacterial Hand",
      "ProprietaryNameSuffix": "Berry Scary",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140729",
      "EndMarketingDate": "20150201",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Bath & Body Works, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "68",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-02-06"
    },
    {
      "NDCCode": "51927-4815-0",
      "PackageDescription": "1 kg in 1 CONTAINER (51927-4815-0)",
      "NDC11Code": "51927-4815-00",
      "ProductNDC": "51927-4815",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Enrofloxacin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20140410",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Professional Compounding Centers of America dba PCCA",
      "SubstanceName": "ENROFLOXACIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "54868-1700-0",
      "PackageDescription": "120 TABLET in 1 BOTTLE (54868-1700-0)",
      "NDC11Code": "54868-1700-00",
      "ProductNDC": "54868-1700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA087463",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
      "Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1  Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2  Acetaminophen USP ........................................................................................325 mg , 3  *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
    },
    {
      "NDCCode": "54868-5024-0",
      "PackageDescription": "60 TABLET in 1 BOTTLE (54868-5024-0)",
      "NDC11Code": "54868-5024-00",
      "ProductNDC": "54868-5024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081014",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040545",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "10; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
      "Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1  Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2  Acetaminophen USP ........................................................................................325 mg , 3  *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
    },
    {
      "NDCCode": "54868-5338-0",
      "PackageDescription": "30 TABLET in 1 BOTTLE (54868-5338-0)",
      "NDC11Code": "54868-5338-00",
      "ProductNDC": "54868-5338",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081014",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040545",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "7.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
      "Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1  Oxycodone Hydrochloride USP ..........................................................................5 mg* , 2  Acetaminophen USP ........................................................................................325 mg , 3  *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
    },
    {
      "NDCCode": "65044-4815-1",
      "PackageDescription": "5 mL in 1 VIAL (65044-4815-1) ",
      "NDC11Code": "65044-4815-01",
      "ProductNDC": "65044-4815",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Cat Hair",
      "NonProprietaryName": "Standardized Cat Hair",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19920924",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103889",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "FELIS CATUS HAIR",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dander [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920924",
      "SamplePackage": "N",
      "IndicationAndUsage": "3, 16, 17, 18 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.19, 20The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to cat dander in kennel owners and employees, cat breeders, research workers, veterinarians, etc. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.",
      "Description": "Allergenic extracts are sterile solutions containing the extractables of the source material and components of the extraction fluid. Standardized Cat Hair is available as an extract from acetone precipitated source material in the extraction fluid described below. Source Material: Cat Hair Source Material consists of hair clippings and/or shavings which have undergone an acetone precipitation process. AP Acetone Precipitated Cat Hair is derived from the precipitate formed when acetone is added to an aqueous extract.Extracting Fluid: Glycero-Coca’s: Contains 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin (v/v) as a preservative. Product Concentration:1. Bioequivalent Allergy Units. When originally licensed, standardized cat extracts containing 10 to 20 Fel d 1 units/mL were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 23 was used to determine that standardized cat extracts containing 10 to 19.9 Fel d 1 units/mL should be assigned 10,000 AU/mL rather than 100,000 AU/mL. To avoid possible confusion about this change in allergy unit assignment, the nomenclature changed for cat extracts, and such products are labeled in Bioequivalent Allergy Units (BAU/mL). Each lot of Standardized Cat Hair extract is standardized by quantitating the Fel d 1 content based on standards on file with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration. Test extracts are diffused in agar containing standard anti-serum to Fel d 1 and compared to the diffusion of a reference cat allergen preparation.2 The potency of the extract is expressed as units of Fel d 1 per mL, and extracts containing 10-19.9 Fel d 1 units per mL are labeled at 10,000 BAU/mL. It has been recognized that there are differences in the levels of non Fel d 1 allergens among standardized cat extracts which utilize different source materials. Isoelectric focusing (IEF) patterns have been shown to be predictive of the presence of non Fel d 1 allergens. Therefore, each lot of Standardized Cat Hair is compared by IEF to a Cat Pelt Extract Reference and a Cat Hair Extract Reference on file with the CBER. The labeled name of the cat extract (i.e., Cat Hair Extract or Cat Pelt Extract) must be supported by matching the IEF profile of the corresponding reference. 2. Concentrate. Concentrate label terminology applies to allergenic extract mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the “Concentrate” mixture, the following formulation may be used:. Ingredients: Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin. Glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 50% glycerin (v/v) as a preservative."
    },
    {
      "NDCCode": "65044-4815-2",
      "PackageDescription": "10 mL in 1 VIAL (65044-4815-2) ",
      "NDC11Code": "65044-4815-02",
      "ProductNDC": "65044-4815",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Cat Hair",
      "NonProprietaryName": "Standardized Cat Hair",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19920924",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103889",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "FELIS CATUS HAIR",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dander [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920924",
      "SamplePackage": "N",
      "IndicationAndUsage": "3, 16, 17, 18 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.19, 20The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to cat dander in kennel owners and employees, cat breeders, research workers, veterinarians, etc. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.",
      "Description": "Allergenic extracts are sterile solutions containing the extractables of the source material and components of the extraction fluid. Standardized Cat Hair is available as an extract from acetone precipitated source material in the extraction fluid described below. Source Material: Cat Hair Source Material consists of hair clippings and/or shavings which have undergone an acetone precipitation process. AP Acetone Precipitated Cat Hair is derived from the precipitate formed when acetone is added to an aqueous extract.Extracting Fluid: Glycero-Coca’s: Contains 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin (v/v) as a preservative. Product Concentration:1. Bioequivalent Allergy Units. When originally licensed, standardized cat extracts containing 10 to 20 Fel d 1 units/mL were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 23 was used to determine that standardized cat extracts containing 10 to 19.9 Fel d 1 units/mL should be assigned 10,000 AU/mL rather than 100,000 AU/mL. To avoid possible confusion about this change in allergy unit assignment, the nomenclature changed for cat extracts, and such products are labeled in Bioequivalent Allergy Units (BAU/mL). Each lot of Standardized Cat Hair extract is standardized by quantitating the Fel d 1 content based on standards on file with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration. Test extracts are diffused in agar containing standard anti-serum to Fel d 1 and compared to the diffusion of a reference cat allergen preparation.2 The potency of the extract is expressed as units of Fel d 1 per mL, and extracts containing 10-19.9 Fel d 1 units per mL are labeled at 10,000 BAU/mL. It has been recognized that there are differences in the levels of non Fel d 1 allergens among standardized cat extracts which utilize different source materials. Isoelectric focusing (IEF) patterns have been shown to be predictive of the presence of non Fel d 1 allergens. Therefore, each lot of Standardized Cat Hair is compared by IEF to a Cat Pelt Extract Reference and a Cat Hair Extract Reference on file with the CBER. The labeled name of the cat extract (i.e., Cat Hair Extract or Cat Pelt Extract) must be supported by matching the IEF profile of the corresponding reference. 2. Concentrate. Concentrate label terminology applies to allergenic extract mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the “Concentrate” mixture, the following formulation may be used:. Ingredients: Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin. Glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 50% glycerin (v/v) as a preservative."
    },
    {
      "NDCCode": "65044-4815-3",
      "PackageDescription": "30 mL in 1 VIAL (65044-4815-3) ",
      "NDC11Code": "65044-4815-03",
      "ProductNDC": "65044-4815",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Cat Hair",
      "NonProprietaryName": "Standardized Cat Hair",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19920924",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103889",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "FELIS CATUS HAIR",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dander [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920924",
      "SamplePackage": "N",
      "IndicationAndUsage": "3, 16, 17, 18 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.19, 20The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to cat dander in kennel owners and employees, cat breeders, research workers, veterinarians, etc. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.",
      "Description": "Allergenic extracts are sterile solutions containing the extractables of the source material and components of the extraction fluid. Standardized Cat Hair is available as an extract from acetone precipitated source material in the extraction fluid described below. Source Material: Cat Hair Source Material consists of hair clippings and/or shavings which have undergone an acetone precipitation process. AP Acetone Precipitated Cat Hair is derived from the precipitate formed when acetone is added to an aqueous extract.Extracting Fluid: Glycero-Coca’s: Contains 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin (v/v) as a preservative. Product Concentration:1. Bioequivalent Allergy Units. When originally licensed, standardized cat extracts containing 10 to 20 Fel d 1 units/mL were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 23 was used to determine that standardized cat extracts containing 10 to 19.9 Fel d 1 units/mL should be assigned 10,000 AU/mL rather than 100,000 AU/mL. To avoid possible confusion about this change in allergy unit assignment, the nomenclature changed for cat extracts, and such products are labeled in Bioequivalent Allergy Units (BAU/mL). Each lot of Standardized Cat Hair extract is standardized by quantitating the Fel d 1 content based on standards on file with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration. Test extracts are diffused in agar containing standard anti-serum to Fel d 1 and compared to the diffusion of a reference cat allergen preparation.2 The potency of the extract is expressed as units of Fel d 1 per mL, and extracts containing 10-19.9 Fel d 1 units per mL are labeled at 10,000 BAU/mL. It has been recognized that there are differences in the levels of non Fel d 1 allergens among standardized cat extracts which utilize different source materials. Isoelectric focusing (IEF) patterns have been shown to be predictive of the presence of non Fel d 1 allergens. Therefore, each lot of Standardized Cat Hair is compared by IEF to a Cat Pelt Extract Reference and a Cat Hair Extract Reference on file with the CBER. The labeled name of the cat extract (i.e., Cat Hair Extract or Cat Pelt Extract) must be supported by matching the IEF profile of the corresponding reference. 2. Concentrate. Concentrate label terminology applies to allergenic extract mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the “Concentrate” mixture, the following formulation may be used:. Ingredients: Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin. Glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 50% glycerin (v/v) as a preservative."
    },
    {
      "NDCCode": "65044-4815-4",
      "PackageDescription": "50 mL in 1 VIAL (65044-4815-4) ",
      "NDC11Code": "65044-4815-04",
      "ProductNDC": "65044-4815",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Cat Hair",
      "NonProprietaryName": "Standardized Cat Hair",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19920924",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103889",
      "LabelerName": "Jubilant HollisterStier LLC",
      "SubstanceName": "FELIS CATUS HAIR",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dander [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920924",
      "SamplePackage": "N",
      "IndicationAndUsage": "3, 16, 17, 18 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.19, 20The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to cat dander in kennel owners and employees, cat breeders, research workers, veterinarians, etc. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.",
      "Description": "Allergenic extracts are sterile solutions containing the extractables of the source material and components of the extraction fluid. Standardized Cat Hair is available as an extract from acetone precipitated source material in the extraction fluid described below. Source Material: Cat Hair Source Material consists of hair clippings and/or shavings which have undergone an acetone precipitation process. AP Acetone Precipitated Cat Hair is derived from the precipitate formed when acetone is added to an aqueous extract.Extracting Fluid: Glycero-Coca’s: Contains 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin (v/v) as a preservative. Product Concentration:1. Bioequivalent Allergy Units. When originally licensed, standardized cat extracts containing 10 to 20 Fel d 1 units/mL were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 23 was used to determine that standardized cat extracts containing 10 to 19.9 Fel d 1 units/mL should be assigned 10,000 AU/mL rather than 100,000 AU/mL. To avoid possible confusion about this change in allergy unit assignment, the nomenclature changed for cat extracts, and such products are labeled in Bioequivalent Allergy Units (BAU/mL). Each lot of Standardized Cat Hair extract is standardized by quantitating the Fel d 1 content based on standards on file with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration. Test extracts are diffused in agar containing standard anti-serum to Fel d 1 and compared to the diffusion of a reference cat allergen preparation.2 The potency of the extract is expressed as units of Fel d 1 per mL, and extracts containing 10-19.9 Fel d 1 units per mL are labeled at 10,000 BAU/mL. It has been recognized that there are differences in the levels of non Fel d 1 allergens among standardized cat extracts which utilize different source materials. Isoelectric focusing (IEF) patterns have been shown to be predictive of the presence of non Fel d 1 allergens. Therefore, each lot of Standardized Cat Hair is compared by IEF to a Cat Pelt Extract Reference and a Cat Hair Extract Reference on file with the CBER. The labeled name of the cat extract (i.e., Cat Hair Extract or Cat Pelt Extract) must be supported by matching the IEF profile of the corresponding reference. 2. Concentrate. Concentrate label terminology applies to allergenic extract mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the “Concentrate” mixture, the following formulation may be used:. Ingredients: Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin. Glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 50% glycerin (v/v) as a preservative."
    },
    {
      "NDCCode": "67296-1392-0",
      "PackageDescription": "40 TABLET in 1 BOTTLE (67296-1392-0) ",
      "NDC11Code": "67296-1392-00",
      "ProductNDC": "67296-1392",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201972",
      "LabelerName": "RedPharm Drug, Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]. Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride And Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains : Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP…………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:. [oxycodone structure]. Oxycodone Hydrochloride and Acetaminophen Tablets contain Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula. [acetaminophen structure]."
    },
    {
      "NDCCode": "67296-1815-0",
      "PackageDescription": "4 TABLET in 1 BOTTLE (67296-1815-0) ",
      "NDC11Code": "67296-1815-00",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-1",
      "PackageDescription": "10 TABLET in 1 BOTTLE (67296-1815-1) ",
      "NDC11Code": "67296-1815-01",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-2",
      "PackageDescription": "20 TABLET in 1 BOTTLE (67296-1815-2) ",
      "NDC11Code": "67296-1815-02",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-3",
      "PackageDescription": "30 TABLET in 1 BOTTLE (67296-1815-3) ",
      "NDC11Code": "67296-1815-03",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-4",
      "PackageDescription": "40 TABLET in 1 BOTTLE (67296-1815-4) ",
      "NDC11Code": "67296-1815-04",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-5",
      "PackageDescription": "50 TABLET in 1 BOTTLE (67296-1815-5) ",
      "NDC11Code": "67296-1815-05",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-6",
      "PackageDescription": "6 TABLET in 1 BOTTLE (67296-1815-6) ",
      "NDC11Code": "67296-1815-06",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-7",
      "PackageDescription": "15 TABLET in 1 BOTTLE (67296-1815-7) ",
      "NDC11Code": "67296-1815-07",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-8",
      "PackageDescription": "12 TABLET in 1 BOTTLE (67296-1815-8) ",
      "NDC11Code": "67296-1815-08",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "67296-1815-9",
      "PackageDescription": "60 TABLET in 1 BOTTLE (67296-1815-9) ",
      "NDC11Code": "67296-1815-09",
      "ProductNDC": "67296-1815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "RedPharm Drug,Inc.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20170411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP…………………………………………………..        2.5 mg * ( *2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP………………………………………………………………       325 mg. Oxycodone hydrochloride, USP ………………………………………………….        5 mg * ( *5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP ……………………………………………………………..         325 mg. Oxycodone hydrochloride, USP…………………………………………………..         7.5 mg * ( *7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP………………………………………………………………        325 mg. Oxycodone hydrochloride, USP……………………………………………………        10.0 mg * ( *10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP  ……………………………………………………………...        325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:."
    },
    {
      "NDCCode": "70518-3492-0",
      "PackageDescription": "100 POUCH in 1 BOX (70518-3492-0)  / 1 TABLET in 1 POUCH (70518-3492-1) ",
      "NDC11Code": "70518-3492-00",
      "ProductNDC": "70518-3492",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220822",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040545",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "325; 10",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220822",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration ( seeWARNINGS), reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg* (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone) Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg* (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone) Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "71335-0146-0",
      "PackageDescription": "112 TABLET in 1 BOTTLE (71335-0146-0) ",
      "NDC11Code": "71335-0146-00",
      "ProductNDC": "71335-0146",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120117",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202677",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "10; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120117",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "71335-0216-0",
      "PackageDescription": "25 TABLET in 1 BOTTLE (71335-0216-0) ",
      "NDC11Code": "71335-0216-00",
      "ProductNDC": "71335-0216",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160309",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202677",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160725",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "71335-0316-0",
      "PackageDescription": "84 TABLET in 1 BOTTLE (71335-0316-0) ",
      "NDC11Code": "71335-0316-00",
      "ProductNDC": "71335-0316",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120117",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202677",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "7.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120117",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "71335-1953-0",
      "PackageDescription": "84 TABLET in 1 BOTTLE (71335-1953-0) ",
      "NDC11Code": "71335-1953-00",
      "ProductNDC": "71335-1953",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "7.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221013",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see Warnings], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains. Oxycodone hydrochloride, USP                                                            2.5 mg*. (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                             5 mg*. (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                            7.5 mg*. (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Oxycodone hydrochloride, USP                                                            10 mg*. (*10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP                                                                            325 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "71335-2041-0",
      "PackageDescription": "25 TABLET in 1 BOTTLE (71335-2041-0) ",
      "NDC11Code": "71335-2041-00",
      "ProductNDC": "71335-2041",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207419",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see Warnings], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
      "Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains:Oxycodone hydrochloride, USP                                                         2.5 mg*(*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.)Acetaminophen, USP                                                                       325 mg. Oxycodone hydrochloride, USP                                                           5 mg*(*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.)Acetaminophen, USP                                                                     325 mg. Oxycodone hydrochloride, USP                                                        7.5 mg*(*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.)Acetaminophen, USP                                                                     325 mg. Oxycodone hydrochloride, USP                                                        10 mg*(*10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.)Acetaminophen, USP                                                                    325 mg. Inactive IngredientsThe tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "71335-9674-0",
      "PackageDescription": "25 TABLET in 1 BOTTLE (71335-9674-0) ",
      "NDC11Code": "71335-9674-00",
      "ProductNDC": "71335-9674",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxycodone And Acetaminophen",
      "NonProprietaryName": "Oxycodone And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207510",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options [e.g., non-opioid analgesics].  Have not been tolerated, or are not expected to be tolerated.  Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone and Acetaminophen Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
      "Description": "Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone hydrochloride USP 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg. Oxycodone hydrochloride, USP 7.5 mg*(*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg. Oxycodone hydrochloride, USP 10 mg*(*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg. Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4'-hydroxyacetanilie, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
    },
    {
      "NDCCode": "62670-3567-0",
      "PackageDescription": "26 g in 1 BOTTLE (62670-3567-0)",
      "NDC11Code": "62670-3567-00",
      "ProductNDC": "62670-3567",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-bacterial Deep Cleansing Hand Gel",
      "ProprietaryNameSuffix": "Fresh Lemon",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333",
      "LabelerName": "Bath & Body Works, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "60",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2014-04-22"
    },
    {
      "NDCCode": "62670-3571-0",
      "PackageDescription": "26 g in 1 BOTTLE (62670-3571-0)",
      "NDC11Code": "62670-3571-00",
      "ProductNDC": "62670-3571",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-bacterial Deep Cleansing Hand Gel",
      "ProprietaryNameSuffix": "Vanilla Bean Noel",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333",
      "LabelerName": "Bath & Body Works, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "60",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-30"
    },
    {
      "NDCCode": "62670-3572-0",
      "PackageDescription": "26 g in 1 BOTTLE (62670-3572-0)",
      "NDC11Code": "62670-3572-00",
      "ProductNDC": "62670-3572",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti-bacterial Deep Cleansing Hand Gel",
      "ProprietaryNameSuffix": "Yuletide Pear Vanilla",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333",
      "LabelerName": "Bath & Body Works, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "60",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2014-04-22"
    }
  ]
}
                    

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Hair</NonProprietaryName></NDC><NDC><NDCCode>65044-4815-2</NDCCode><ProprietaryName>Standardized Cat Hair</ProprietaryName><NonProprietaryName>Standardized Cat Hair</NonProprietaryName></NDC><NDC><NDCCode>65044-4815-3</NDCCode><ProprietaryName>Standardized Cat Hair</ProprietaryName><NonProprietaryName>Standardized Cat Hair</NonProprietaryName></NDC><NDC><NDCCode>65044-4815-4</NDCCode><ProprietaryName>Standardized Cat Hair</ProprietaryName><NonProprietaryName>Standardized Cat Hair</NonProprietaryName></NDC><NDC><NDCCode>67296-1392-0</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67296-1815-0</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67296-1815-1</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67296-1815-2</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67296-1815-3</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67296-1815-4</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67296-1815-5</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67296-1815-6</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67296-1815-7</NDCCode><ProprietaryName>Oxycodone And 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Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>71335-0316-0</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>71335-1953-0</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>71335-2041-0</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>71335-9674-0</NDCCode><ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName><NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>62670-3567-0</NDCCode><ProprietaryName>Anti-bacterial Deep Cleansing Hand Gel</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>62670-3571-0</NDCCode><ProprietaryName>Anti-bacterial Deep Cleansing Hand Gel</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>62670-3572-0</NDCCode><ProprietaryName>Anti-bacterial Deep Cleansing Hand Gel</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC></NDCList>