RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "53877-008-71",
      "PackageDescription": "18 BAG in 1 CASE (53877-008-71)  > 1 KIT in 1 BAG *  70 mL in 1 BAG *  111 mL in 1 BAG",
      "NDC11Code": "53877-0008-71",
      "ProductNDC": "53877-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
      "DosageFormName": "KIT",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20100505",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN880217",
      "LabelerName": "Terumo Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20100505",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1. Read these instructions carefully before use. 1.2. Rx ONLY. 1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion. 1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood. 1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 1.6. For further processing, use standard component processing techniques.",
      "Description": "11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and either a 450mL or 500mL (nominal capacity 600mL) primary collection bag containing 63 mL or 70mL, respectively, Citrate Phosphate Dextrose (CPD) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. The Triple blood bag set has one empty XT-612 5 day Platelet bag and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. The Quadruple blood bag set has one integrally attached empty XT-612 5 day Platelet bag, one empty satellite bag, and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare® Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-008-51",
      "PackageDescription": "24 BAG in 1 CASE (53877-008-51)  > 1 KIT in 1 BAG *  63 mL in 1 BAG *  100 mL in 1 BAG",
      "NDC11Code": "53877-0008-51",
      "ProductNDC": "53877-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
      "DosageFormName": "KIT",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20100505",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN880217",
      "LabelerName": "Terumo Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20100505",
      "SamplePackage": "N",
      "IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 hereCAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
    },
    {
      "NDCCode": "53877-008-61",
      "PackageDescription": "24 BAG in 1 CASE (53877-008-61)  > 1 KIT in 1 BAG *  70 mL in 1 BAG *  111 mL in 1 BAG",
      "NDC11Code": "53877-0008-61",
      "ProductNDC": "53877-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
      "DosageFormName": "KIT",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20100505",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN880217",
      "LabelerName": "Terumo Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20100505",
      "SamplePackage": "N",
      "IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
    },
    {
      "NDCCode": "53877-008-81",
      "PackageDescription": "18 BAG in 1 CASE (53877-008-81)  > 1 KIT in 1 BAG *  63 mL in 1 BAG *  100 mL in 1 BAG",
      "NDC11Code": "53877-0008-81",
      "ProductNDC": "53877-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
      "DosageFormName": "KIT",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20100505",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN880217",
      "LabelerName": "Terumo Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20100505",
      "SamplePackage": "N",
      "IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 here. b) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here. 6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
    },
    {
      "NDCCode": "41701-008-72",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (41701-008-72)  / 1 g in 1 BOTTLE, PLASTIC (41701-008-71) ",
      "NDC11Code": "41701-0008-72",
      "ProductNDC": "41701-008",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Vasopressin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20160328",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Piramal Pharma Limited",
      "SubstanceName": "VASOPRESSIN, UNSPECIFIED",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2024-01-23",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "28-MAR-16"
    },
    {
      "NDCCode": "53943-008-25",
      "PackageDescription": "71 g in 1 BOTTLE, PLASTIC (53943-008-25) ",
      "NDC11Code": "53943-0008-25",
      "ProductNDC": "53943-008",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Miconazole Nitrate",
      "NonProprietaryName": "Miconazorb Af Powder",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171219",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Discount Drug Mart",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "1.42",
      "StrengthUnit": "g/71g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20171219",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the cure of most athlete's foot, jock itch and ringworm."
    },
    {
      "NDCCode": "75706-008-05",
      "PackageDescription": "1892.71 mL in 1 BOTTLE, PUMP (75706-008-05) ",
      "NDC11Code": "75706-0008-05",
      "ProductNDC": "75706-008",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Evonik Corporation",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "80199-008-02",
      "PackageDescription": "80 PATCH in 1 BOX (80199-008-02)  > 1.71 mL in 1 PATCH",
      "NDC11Code": "80199-0008-02",
      "ProductNDC": "80199-008",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "75 Alcohol Hand Sanitizing Wipes",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200820",
      "EndMarketingDate": "20211030",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "E-Fresh Food Ltd.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".75",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-11-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200929",
      "EndMarketingDatePackage": "20211030",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0409-1746-30",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1746-30)  / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1746-71) ",
      "NDC11Code": "00409-1746-30",
      "ProductNDC": "0409-1746",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Marcaine With Epinephrine",
      "NonProprietaryName": "Bupivacaine Hydrochloride And Epinephrine Bitartrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20050912",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016964",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "2.5; .0091",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20050912",
      "SamplePackage": "N",
      "IndicationAndUsage": "MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
      "Description": "MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008."
    },
    {
      "NDCCode": "0409-1749-29",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1749-29)  / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1749-71) ",
      "NDC11Code": "00409-1749-29",
      "ProductNDC": "0409-1749",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Marcaine With Epinephrine",
      "NonProprietaryName": "Bupivacaine Hydrochloride And Epinephrine Bitartrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20050912",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016964",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "5; .0091",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20050912",
      "SamplePackage": "N",
      "IndicationAndUsage": "MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
      "Description": "MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008."
    },
    {
      "NDCCode": "16590-008-10",
      "PackageDescription": "10 CAPSULE in 1 BOTTLE (16590-008-10)",
      "NDC11Code": "16590-0008-10",
      "ProductNDC": "16590-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amantadine Hydrochloride",
      "NonProprietaryName": "Amantadine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19870218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071293",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "AMANTADINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
      "Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide."
    },
    {
      "NDCCode": "16590-008-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (16590-008-30)",
      "NDC11Code": "16590-0008-30",
      "ProductNDC": "16590-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amantadine Hydrochloride",
      "NonProprietaryName": "Amantadine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19870218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071293",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "AMANTADINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
      "Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide."
    },
    {
      "NDCCode": "16590-008-60",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (16590-008-60)",
      "NDC11Code": "16590-0008-60",
      "ProductNDC": "16590-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amantadine Hydrochloride",
      "NonProprietaryName": "Amantadine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19870218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071293",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "AMANTADINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
      "Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide."
    },
    {
      "NDCCode": "16590-008-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (16590-008-90)",
      "NDC11Code": "16590-0008-90",
      "ProductNDC": "16590-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amantadine Hydrochloride",
      "NonProprietaryName": "Amantadine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19870218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071293",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "AMANTADINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
      "Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide."
    },
    {
      "NDCCode": "55455-008-01",
      "PackageDescription": "720 mL in 1 BOTTLE (55455-008-01) ",
      "NDC11Code": "55455-0008-01",
      "ProductNDC": "55455-008",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Youjie Weishi Cloth Cleaning Disinfectant",
      "NonProprietaryName": "Cloth Cleaning Disinfectant",
      "DosageFormName": "LIQUID",
      "RouteName": "EXTRACORPOREAL",
      "StartMarketingDate": "20200402",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Hebei Youjie Weishi Technology Co., Ltd.",
      "SubstanceName": "BENZODODECINIUM BROMIDE; METHENAMINE",
      "StrengthNumber": "38.16; 71.28",
      "StrengthUnit": "g/720mL; g/720mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200402",
      "SamplePackage": "N",
      "IndicationAndUsage": "1 .Hand Wash; Dilute the product evenly in clean water at a diution rate of 1:100 into a diluent for use; immerse cloth in the diluent for 10-20 minutes (for disinfection); scrub (if applicable) the cloth; wash the cloth with clean water, dry the cloth. 2. Machine Wash. Put a right amount of the product into the material storage box of the washing machine, start the cloth washing process."
    },
    {
      "NDCCode": "73362-008-01",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-008-01)  / 1 CARTRIDGE in 1 BLISTER PACK (73362-008-02)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
      "NDC11Code": "73362-0008-01",
      "ProductNDC": "73362-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Skytrofa",
      "NonProprietaryName": "Lonapegsomatropin-tcgd",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20210825",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761177",
      "LabelerName": "Ascendis Pharma Endocrinology, Inc.",
      "SubstanceName": "LONAPEGSOMATROPIN",
      "StrengthNumber": "7.6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210825",
      "SamplePackage": "N",
      "IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
      "Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
    },
    {
      "NDCCode": "53877-001-01",
      "PackageDescription": "30 BAG in 1 CASE (53877-001-01)  > 35 mL in 1 BAG",
      "NDC11Code": "53877-0001-01",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091118",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091118",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the collection of 250 mL of Whole Blood. Revised 2015-12 N-BB-A 3. FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.   INDICATIONS AND USAGE1.1.   Read these instructions carefully before use. 1.2.   Rx ONLY.1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 250 mL ±10% Whole Blood:    1.4.1.    From elderly, pediatric, or smaller autologous donors who may not tolerate larger blood collections.    1.4.2.    For blood collections as directed by a patient's physician.1.5.   NOTE: Production of Platelets and Plasma is not intended with this product.",
      "Description": "11.   DESCRIPTION. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 250 mL (nominal capacity 300 mL) collection bag containing 35 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. 11.2.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3.   The blood bag has no components made of natural rubber latex. 11.4.   Tubing internal diameter (ID) nominal 3.0 mm. 11.5.   Tubing outer diameter (OD) nominal 4.4 mm. 11.6.   Donor tubing line maximum 12 segments available."
    },
    {
      "NDCCode": "53877-001-02",
      "PackageDescription": "30 BAG in 1 CASE (53877-001-02)  > 63 mL in 1 BAG",
      "NDC11Code": "53877-0001-02",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Revised 2011-11 N-BB-CA-A 5BB89X505+5FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.   INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL +/- 10% Whole Blood.1.5.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 450 mL (nominal capacity 600 mL) primary collection bag containing 63 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3.   The blood bag has no components made of natural rubber latex. 11.4.   Tubing internal diameter (ID) nominal 3.0 mm. 11.5.   Tubing outer diameter (OD) nominal 4.4 mm. 11.6.   Donor tubing line maximum 19 segments available."
    },
    {
      "NDCCode": "53877-001-03",
      "PackageDescription": "60 BAG in 1 CASE (53877-001-03)  > 63 mL in 1 BAG",
      "NDC11Code": "53877-0001-03",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Revised 2011-11 N-BB-CA-A 5BB89X505+5FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.   INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL +/- 10% Whole Blood.1.5.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 450 mL (nominal capacity 600 mL) primary collection bag containing 63 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3.   The blood bag has no components made of natural rubber latex. 11.4.   Tubing internal diameter (ID) nominal 3.0 mm. 11.5.   Tubing outer diameter (OD) nominal 4.4 mm. 11.6.   Donor tubing line maximum 19 segments available."
    },
    {
      "NDCCode": "53877-001-04",
      "PackageDescription": "48 BAG in 1 CASE (53877-001-04)  > 63 mL in 1 BAG",
      "NDC11Code": "53877-0001-04",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091214",
      "SamplePackage": "N",
      "IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY.1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5.   Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood  bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-05",
      "PackageDescription": "30 BAG in 1 CASE (53877-001-05)  > 63 mL in 1 BAG",
      "NDC11Code": "53877-0001-05",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091214",
      "SamplePackage": "N",
      "IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY.1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5.   Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood  bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-06",
      "PackageDescription": "36 BAG in 1 CASE (53877-001-06)  > 70 mL in 1 BAG",
      "NDC11Code": "53877-0001-06",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091214",
      "SamplePackage": "N",
      "IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY.1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5.   Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood  bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-07",
      "PackageDescription": "30 BAG in 1 CASE (53877-001-07)  > 70 mL in 1 BAG",
      "NDC11Code": "53877-0001-07",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091214",
      "SamplePackage": "N",
      "IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY.1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5.   Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood  bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-08",
      "PackageDescription": "24 BAG in 1 CASE (53877-001-08)  > 70 mL in 1 BAG",
      "NDC11Code": "53877-0001-08",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091214",
      "SamplePackage": "N",
      "IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY.1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5.   Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood  bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-09",
      "PackageDescription": "24 BAG in 1 CASE (53877-001-09)  > 63 mL in 1 BAG",
      "NDC11Code": "53877-0001-09",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091214",
      "SamplePackage": "N",
      "IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY.1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5.   Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood  bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-10",
      "PackageDescription": "36 BAG in 1 CASE (53877-001-10)  > 63 mL in 1 BAG",
      "NDC11Code": "53877-0001-10",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20091214",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20091214",
      "SamplePackage": "N",
      "IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY.1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5.   Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood  bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-11",
      "PackageDescription": "30 BAG in 1 CASE (53877-001-11)  > 63 mL in 1 BAG",
      "NDC11Code": "53877-0001-11",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120522",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20120522",
      "SamplePackage": "N",
      "IndicationAndUsage": "Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5.   Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-12",
      "PackageDescription": "24 BAG in 1 CASE (53877-001-12)  > 63 mL in 1 BAG",
      "NDC11Code": "53877-0001-12",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120522",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20120522",
      "SamplePackage": "N",
      "IndicationAndUsage": "Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5.   Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-13",
      "PackageDescription": "30 BAG in 1 CASE (53877-001-13)  > 70 mL in 1 BAG",
      "NDC11Code": "53877-0001-13",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120522",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20120522",
      "SamplePackage": "N",
      "IndicationAndUsage": "Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5.   Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    },
    {
      "NDCCode": "53877-001-14",
      "PackageDescription": "24 BAG in 1 CASE (53877-001-14)  > 70 mL in 1 BAG",
      "NDC11Code": "53877-0001-14",
      "ProductNDC": "53877-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120522",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820528",
      "LabelerName": "Terumo Corporation",
      "SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
      "StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20120522",
      "SamplePackage": "N",
      "IndicationAndUsage": "Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1.    INDICATIONS AND USAGE1.1.   Read these instructions carefully before use.1.2.   Rx ONLY1.3.   Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.   For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5.   Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6.   For further processing, use standard component processing techniques.",
      "Description": "11.   DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1.   This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2.   Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3.   Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4.   The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5.   The blood bag has no components made of natural rubber latex. 11.6.   Tubing internal diameter (ID) nominal 3.0 mm. 11.7.   Tubing outer diameter (OD) nominal 4.4 mm. 11.8.   Donor tubing line maximum 16 segments available."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"53877-008-71","ProprietaryName":"Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative"},{"NDCCode":"53877-008-51","ProprietaryName":"Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative"},{"NDCCode":"53877-008-61","ProprietaryName":"Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative"},{"NDCCode":"53877-008-81","ProprietaryName":"Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative"},{"NDCCode":"41701-008-72","NonProprietaryName":"Vasopressin"},{"NDCCode":"53943-008-25","ProprietaryName":"Miconazole Nitrate","NonProprietaryName":"Miconazorb Af Powder"},{"NDCCode":"75706-008-05","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"80199-008-02","ProprietaryName":"75 Alcohol Hand Sanitizing Wipes","NonProprietaryName":"Alcohol"},{"NDCCode":"0409-1746-30","ProprietaryName":"Marcaine With Epinephrine","NonProprietaryName":"Bupivacaine Hydrochloride And Epinephrine Bitartrate"},{"NDCCode":"0409-1749-29","ProprietaryName":"Marcaine With Epinephrine","NonProprietaryName":"Bupivacaine Hydrochloride And Epinephrine Bitartrate"},{"NDCCode":"16590-008-10","ProprietaryName":"Amantadine Hydrochloride","NonProprietaryName":"Amantadine Hydrochloride"},{"NDCCode":"16590-008-30","ProprietaryName":"Amantadine Hydrochloride","NonProprietaryName":"Amantadine Hydrochloride"},{"NDCCode":"16590-008-60","ProprietaryName":"Amantadine Hydrochloride","NonProprietaryName":"Amantadine Hydrochloride"},{"NDCCode":"16590-008-90","ProprietaryName":"Amantadine Hydrochloride","NonProprietaryName":"Amantadine Hydrochloride"},{"NDCCode":"55455-008-01","ProprietaryName":"Youjie Weishi Cloth Cleaning Disinfectant","NonProprietaryName":"Cloth Cleaning Disinfectant"},{"NDCCode":"73362-008-01","ProprietaryName":"Skytrofa","NonProprietaryName":"Lonapegsomatropin-tcgd"},{"NDCCode":"53877-001-01","ProprietaryName":"Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)"},{"NDCCode":"53877-001-02","ProprietaryName":"Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)"},{"NDCCode":"53877-001-03","ProprietaryName":"Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)"},{"NDCCode":"53877-001-04","ProprietaryName":"Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)"},{"NDCCode":"53877-001-05","ProprietaryName":"Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)"},{"NDCCode":"53877-001-06","ProprietaryName":"Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)","NonProprietaryName":"Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)"},{"NDCCode":"53877-001-07","ProprietaryName":"Teruflex Blood Bag System Anticoagulant Citrate Phosphate 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Preservative</NonProprietaryName></NDC><NDC><NDCCode>53877-008-81</NDCCode><ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName></NDC><NDC><NDCCode>41701-008-72</NDCCode><NonProprietaryName>Vasopressin</NonProprietaryName></NDC><NDC><NDCCode>53943-008-25</NDCCode><ProprietaryName>Miconazole Nitrate</ProprietaryName><NonProprietaryName>Miconazorb Af Powder</NonProprietaryName></NDC><NDC><NDCCode>75706-008-05</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>80199-008-02</NDCCode><ProprietaryName>75 Alcohol Hand Sanitizing Wipes</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>0409-1746-30</NDCCode><ProprietaryName>Marcaine With Epinephrine</ProprietaryName><NonProprietaryName>Bupivacaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>0409-1749-29</NDCCode><ProprietaryName>Marcaine With Epinephrine</ProprietaryName><NonProprietaryName>Bupivacaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName></NDC><NDC><NDCCode>16590-008-10</NDCCode><ProprietaryName>Amantadine Hydrochloride</ProprietaryName><NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-008-30</NDCCode><ProprietaryName>Amantadine Hydrochloride</ProprietaryName><NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-008-60</NDCCode><ProprietaryName>Amantadine Hydrochloride</ProprietaryName><NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-008-90</NDCCode><ProprietaryName>Amantadine Hydrochloride</ProprietaryName><NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55455-008-01</NDCCode><ProprietaryName>Youjie Weishi Cloth Cleaning Disinfectant</ProprietaryName><NonProprietaryName>Cloth Cleaning Disinfectant</NonProprietaryName></NDC><NDC><NDCCode>73362-008-01</NDCCode><ProprietaryName>Skytrofa</ProprietaryName><NonProprietaryName>Lonapegsomatropin-tcgd</NonProprietaryName></NDC><NDC><NDCCode>53877-001-01</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-02</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-03</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-04</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-05</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-06</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-07</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-08</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-09</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-10</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-11</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-12</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-13</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC><NDC><NDCCode>53877-001-14</NDCCode><ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName></NDC></NDCList>