{
"NDC": [
{
"NDCCode": "53877-009-31",
"PackageDescription": "24 BAG in 1 CASE (53877-009-31) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG",
"NDC11Code": "53877-0009-31",
"ProductNDC": "53877-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With 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 8/96 TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000) VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or plastic evacuated blood collection tube)1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.2. Make a loose knot in donor tubing below \"Y\" unless alternate methods are used to seal tubing.3. Clamp donor tubing.4. Suspend primary bag as far as possible below the donor's arm.5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 60 mmHg.6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag.CAUTION Do not touch needle after removing the needle protector. 7. Appropriately secure donor tubing to donor's arm.8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION. 9. Collect labeled volume of blood (+/–10%).10. Tighten knot firmly after collection. Clamp between knot and \"Y\". Sever donor tubing between the knot and clamp. Alternate methods may be used to seal tubing.CAUTION Do not use the dielectric tube sealer while the needle is connected to the donor's body.Anytime before Step #13 below, sever donor tubing between the two seals.Collect blood samples as follows:a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube Holder (Fig. 1).b) Remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (Fig. 2).c) Snap CLIKTIP in donor sampling tubing to open blood pathway.Insert Fig. 1 here. Insert Fig. 2 here. d) Insert blood collection tube (VENOJECT II or equivalent) firmly into VENOJECT II Tube Holder : when full, remove sample tube from holder. Repeat to collect additional samples.11. Reapply clamp to donor tubing between phlebotomy needle and \"Y\"; release pressure on donor's arm and remove needle.CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures. 12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.13. Strip blood from the donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.14. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions.a) After removal of plasma from freshly collected blood.b) Within 8 hours of blood collection if components are prepared.c) Within 72 hours of collection if blood is refrigerated immediately following collection.15. Centrifuge the unit to separate red cells from plasma.16. Snap CLlKTIP (inline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.17. Snap 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 seals and 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.18. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.19. Store AS-5 Red Blood Cells between 1-6°C.20. 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. 3 here. CAUTIONSTHE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE. DISPOSE WITH PACKET IN TRAY. DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS. DISCARD AGELESS PACKET WITHOUT OPENING.TERUMO® TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN ®: Registered Trademark N-BB-OP-A(SP) 3."
},
{
"NDCCode": "53877-009-41",
"PackageDescription": "24 BAG in 1 CASE (53877-009-41) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG",
"NDC11Code": "53877-0009-41",
"ProductNDC": "53877-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With 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 8/96 TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000) VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or plastic evacuated blood collection tube)1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.2. Make a loose knot in donor tubing below \"Y\" unless alternate methods are used to seal tubing.3. Clamp donor tubing.4. Suspend primary bag as far as possible below the donor's arm.5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 60 mmHg.6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag.CAUTION Do not touch needle after removing the needle protector. 7. Appropriately secure donor tubing to donor's arm.8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION. 9. Collect labeled volume of blood (+/–10%).10. Tighten knot firmly after collection. Clamp between knot and \"Y\". Sever donor tubing between the knot and clamp. Alternate methods may be used to seal tubing.CAUTION Do not use the dielectric tube sealer while the needle is connected to the donor's body.Anytime before Step #13 below, sever donor tubing between the two seals.Collect blood samples as follows:a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube Holder (Fig. 1).b) Remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (Fig. 2).c) Snap CLIKTIP in donor sampling tubing to open blood pathway.Insert Fig. 1 here. Insert Fig. 2 here. d) Insert blood collection tube (VENOJECT II or equivalent) firmly into VENOJECT II Tube Holder : when full, remove sample tube from holder. Repeat to collect additional samples.11. Reapply clamp to donor tubing between phlebotomy needle and \"Y\"; release pressure on donor's arm and remove needle.CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures. 12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.13. Strip blood from the donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.14. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions.a) After removal of plasma from freshly collected blood.b) Within 8 hours of blood collection if components are prepared.c) Within 72 hours of collection if blood is refrigerated immediately following collection.15. Centrifuge the unit to separate red cells from plasma.16. Snap CLlKTIP (inline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.17. Snap 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 seals and 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.18. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.19. Store AS-5 Red Blood Cells between 1-6°C.20. 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. 3 here. CAUTIONSTHE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE. DISPOSE WITH PACKET IN TRAY. DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS. DISCARD AGELESS PACKET WITHOUT OPENING.TERUMO® TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN ®: Registered Trademark N-BB-OP-A(SP) 3."
},
{
"NDCCode": "53877-006-31",
"PackageDescription": "18 BAG in 1 CASE (53877-006-31) / 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG",
"NDC11Code": "53877-0006-31",
"ProductNDC": "53877-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imuflex Wb-rp Blood Bag System With Integral Whole Blood Leukocyte Reduction Filter (removing Platelets) 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": "20100226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100226",
"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 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. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature or cooled towards 1-10°C (transport temperature). 1.7. 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 a 500mL (nominal capacity 600mL) collection bag containing 70mL Citrate Phosphate Dextrose (CPD) anticoagulant. The Quadruple blood bag set has one integrally attached empty primary bag, one empty satellite bag, and one satellite bag containing 111 mL OPTISOL Red Cell Preservative Solution. 11.2. Blood bag codes ending in A2 are the collection set with an Integral Diversion Blood Sampling Arm for obtaining donor samples 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. Tubing line maximum 16 segments available."
},
{
"NDCCode": "11054-009-31",
"PackageDescription": "1627 L in 1 CYLINDER (11054-009-31) ",
"NDC11Code": "11054-0009-31",
"ProductNDC": "11054-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "CUTANEOUS; RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971014",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205840",
"LabelerName": "Airgas USA, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19971014",
"SamplePackage": "N"
},
{
"NDCCode": "62332-009-31",
"PackageDescription": "100 TABLET in 1 BOTTLE (62332-009-31) ",
"NDC11Code": "62332-0009-31",
"ProductNDC": "62332-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078932",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone."
},
{
"NDCCode": "80948-009-31",
"PackageDescription": "200000 mL in 1 DRUM (80948-009-31) ",
"NDC11Code": "80948-0009-31",
"ProductNDC": "80948-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Puroma Hand Sanitizer Fragrance Free",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210311",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "ZENITH MICRO CONTROL",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210311",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria on skin."
},
{
"NDCCode": "82123-009-31",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (82123-009-31) / 30 mL in 1 BOTTLE, GLASS (82123-009-30) ",
"NDC11Code": "82123-0009-31",
"ProductNDC": "82123-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Propolis Nasal",
"NonProprietaryName": "Nasal",
"DosageFormName": "LIQUID",
"RouteName": "NASAL",
"StartMarketingDate": "20231002",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".015",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231002",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"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."
},
{
"NDCCode": "53877-006-06",
"PackageDescription": "6 BLISTER PACK in 1 CASE (53877-006-06) / 3 BAG in 1 BLISTER PACK (53877-006-01) / 1 KIT in 1 BAG (53877-006-02) * 70 mL in 1 BAG * 111 mL in 1 BAG",
"NDC11Code": "53877-0006-06",
"ProductNDC": "53877-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imuflex Wb-rp Blood Bag System With Integral Whole Blood Leukocyte Reduction Filter (removing Platelets) 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": "20100226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100226",
"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 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. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature or cooled towards 1-10°C (transport temperature). 1.7. 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 a 500mL (nominal capacity 600mL) collection bag containing 70mL Citrate Phosphate Dextrose (CPD) anticoagulant. The Quadruple blood bag set has one integrally attached empty primary bag, one empty satellite bag, and one satellite bag containing 111 mL OPTISOL Red Cell Preservative Solution. 11.2. Blood bag codes ending in A2 are the collection set with an Integral Diversion Blood Sampling Arm for obtaining donor samples 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. Tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-108-06",
"PackageDescription": "6 BLISTER PACK in 1 CASE (53877-108-06) / 4 BAG in 1 BLISTER PACK (53877-108-01) / 63 mL in 1 BAG (53877-108-02) ",
"NDC11Code": "53877-0108-06",
"ProductNDC": "53877-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) For Collection Of 450ml Of Blood",
"NonProprietaryName": "Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE",
"StrengthNumber": "2.99; 26.3; 2.22; 31.9; .275",
"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": "Active",
"LastUpdate": "2024-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091214",
"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 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": "53877-109-06",
"PackageDescription": "6 BLISTER PACK in 1 CASE (53877-109-06) / 4 BAG in 1 BLISTER PACK (53877-109-01) / 70 mL in 1 BAG (53877-109-02) ",
"NDC11Code": "53877-0109-06",
"ProductNDC": "53877-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood With Diversion Blood Sampling Arm 70 Ml Cpda-1",
"NonProprietaryName": "Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE",
"StrengthNumber": "2.99; 26.3; 2.22; 31.9; .275",
"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": "Active",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120522",
"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 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": "53877-110-06",
"PackageDescription": "6 BLISTER PACK in 1 CASE (53877-110-06) / 5 BAG in 1 BLISTER PACK (53877-110-01) / 70 mL in 1 BAG (53877-110-02) ",
"NDC11Code": "53877-0110-06",
"ProductNDC": "53877-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm 70 Ml Cpda-1",
"NonProprietaryName": "Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE",
"StrengthNumber": "2.99; 26.3; 2.22; 31.9; .275",
"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": "Active",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120522",
"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 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": "13537-119-32",
"PackageDescription": "1 TUBE in 1 BOX (13537-119-32) > 4 g in 1 TUBE (13537-119-31)",
"NDC11Code": "13537-0119-32",
"ProductNDC": "13537-119",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Couleur Luxe Rouge Amplifier Xp Amplifying Spf 15",
"ProprietaryNameSuffix": "(dore Chocolat) - Brown",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140127",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".047; .009",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "49698-009-01",
"PackageDescription": "1 CASE in 1 CARTON (49698-009-01) / 80 g in 1 CASE",
"NDC11Code": "49698-0009-01",
"ProductNDC": "49698-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Asepso Herbal Scented Antiseptic",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "CODAA SWITZERLAND AG",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "50269-009-06",
"PackageDescription": "6 BLISTER PACK in 1 BOX (50269-009-06) / 2 POUCH in 1 BLISTER PACK / 2 TABLET in 1 POUCH",
"NDC11Code": "50269-0009-06",
"ProductNDC": "50269-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Midol Complete",
"NonProprietaryName": "Acetaminophen, Caffeine, Pyrilamine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191120",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "JC World Bell Wholesale Co., Inc.",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE",
"StrengthNumber": "500; 60; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191120",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water-weight gain, 4 headache, 5 backache, 6 muscle aches, 7 fatigue."
},
{
"NDCCode": "53206-009-20",
"PackageDescription": "20412 kg in 1 TANK (53206-009-20) ",
"NDC11Code": "53206-0009-20",
"ProductNDC": "53206-009",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"StartMarketingDate": "20191231",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Caldic USA Inc",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "31-DEC-19"
},
{
"NDCCode": "58793-009-01",
"PackageDescription": "25 kg in 1 DRUM (58793-009-01) ",
"NDC11Code": "58793-0009-01",
"ProductNDC": "58793-009",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20161222",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kreative Organics Private Limited",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": ".85",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "22-DEC-16",
"EndMarketingDatePackage": "31-JAN-25"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>53877-009-31</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-009-31) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0009-31</NDC11Code>
<ProductNDC>53877-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With 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>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 8/96 TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000) VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or plastic evacuated blood collection tube)1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.2. Make a loose knot in donor tubing below "Y" unless alternate methods are used to seal tubing.3. Clamp donor tubing.4. Suspend primary bag as far as possible below the donor's arm.5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 60 mmHg.6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag.CAUTION Do not touch needle after removing the needle protector. 7. Appropriately secure donor tubing to donor's arm.8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION. 9. Collect labeled volume of blood (+/–10%).10. Tighten knot firmly after collection. Clamp between knot and "Y". Sever donor tubing between the knot and clamp. Alternate methods may be used to seal tubing.CAUTION Do not use the dielectric tube sealer while the needle is connected to the donor's body.Anytime before Step #13 below, sever donor tubing between the two seals.Collect blood samples as follows:a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube Holder (Fig. 1).b) Remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (Fig. 2).c) Snap CLIKTIP in donor sampling tubing to open blood pathway.Insert Fig. 1 here. Insert Fig. 2 here. d) Insert blood collection tube (VENOJECT II or equivalent) firmly into VENOJECT II Tube Holder : when full, remove sample tube from holder. Repeat to collect additional samples.11. Reapply clamp to donor tubing between phlebotomy needle and "Y"; release pressure on donor's arm and remove needle.CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures. 12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.13. Strip blood from the donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.14. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions.a) After removal of plasma from freshly collected blood.b) Within 8 hours of blood collection if components are prepared.c) Within 72 hours of collection if blood is refrigerated immediately following collection.15. Centrifuge the unit to separate red cells from plasma.16. Snap CLlKTIP (inline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.17. Snap 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 seals and 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.18. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.19. Store AS-5 Red Blood Cells between 1-6°C.20. 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. 3 here. CAUTIONSTHE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE. DISPOSE WITH PACKET IN TRAY. DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS. DISCARD AGELESS PACKET WITHOUT OPENING.TERUMO® TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN ®: Registered Trademark N-BB-OP-A(SP) 3.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-009-41</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-009-41) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0009-41</NDC11Code>
<ProductNDC>53877-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With 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>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 8/96 TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000) VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or plastic evacuated blood collection tube)1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.2. Make a loose knot in donor tubing below "Y" unless alternate methods are used to seal tubing.3. Clamp donor tubing.4. Suspend primary bag as far as possible below the donor's arm.5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 60 mmHg.6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag.CAUTION Do not touch needle after removing the needle protector. 7. Appropriately secure donor tubing to donor's arm.8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION. 9. Collect labeled volume of blood (+/–10%).10. Tighten knot firmly after collection. Clamp between knot and "Y". Sever donor tubing between the knot and clamp. Alternate methods may be used to seal tubing.CAUTION Do not use the dielectric tube sealer while the needle is connected to the donor's body.Anytime before Step #13 below, sever donor tubing between the two seals.Collect blood samples as follows:a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube Holder (Fig. 1).b) Remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (Fig. 2).c) Snap CLIKTIP in donor sampling tubing to open blood pathway.Insert Fig. 1 here. Insert Fig. 2 here. d) Insert blood collection tube (VENOJECT II or equivalent) firmly into VENOJECT II Tube Holder : when full, remove sample tube from holder. Repeat to collect additional samples.11. Reapply clamp to donor tubing between phlebotomy needle and "Y"; release pressure on donor's arm and remove needle.CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures. 12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.13. Strip blood from the donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.14. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions.a) After removal of plasma from freshly collected blood.b) Within 8 hours of blood collection if components are prepared.c) Within 72 hours of collection if blood is refrigerated immediately following collection.15. Centrifuge the unit to separate red cells from plasma.16. Snap CLlKTIP (inline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.17. Snap 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 seals and 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.18. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.19. Store AS-5 Red Blood Cells between 1-6°C.20. 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. 3 here. CAUTIONSTHE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE. DISPOSE WITH PACKET IN TRAY. DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS. DISCARD AGELESS PACKET WITHOUT OPENING.TERUMO® TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN ®: Registered Trademark N-BB-OP-A(SP) 3.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-006-31</NDCCode>
<PackageDescription>18 BAG in 1 CASE (53877-006-31) / 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0006-31</NDC11Code>
<ProductNDC>53877-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imuflex Wb-rp Blood Bag System With Integral Whole Blood Leukocyte Reduction Filter (removing Platelets) 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>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 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. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature or cooled towards 1-10°C (transport temperature). 1.7. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and a 500mL (nominal capacity 600mL) collection bag containing 70mL Citrate Phosphate Dextrose (CPD) anticoagulant. The Quadruple blood bag set has one integrally attached empty primary bag, one empty satellite bag, and one satellite bag containing 111 mL OPTISOL Red Cell Preservative Solution. 11.2. Blood bag codes ending in A2 are the collection set with an Integral Diversion Blood Sampling Arm for obtaining donor samples 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. Tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>11054-009-31</NDCCode>
<PackageDescription>1627 L in 1 CYLINDER (11054-009-31) </PackageDescription>
<NDC11Code>11054-0009-31</NDC11Code>
<ProductNDC>11054-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>CUTANEOUS; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971014</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205840</ApplicationNumber>
<LabelerName>Airgas USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62332-009-31</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62332-009-31) </PackageDescription>
<NDC11Code>62332-0009-31</NDC11Code>
<ProductNDC>62332-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078932</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>80948-009-31</NDCCode>
<PackageDescription>200000 mL in 1 DRUM (80948-009-31) </PackageDescription>
<NDC11Code>80948-0009-31</NDC11Code>
<ProductNDC>80948-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Puroma Hand Sanitizer Fragrance Free</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210311</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ZENITH MICRO CONTROL</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82123-009-31</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (82123-009-31) / 30 mL in 1 BOTTLE, GLASS (82123-009-30) </PackageDescription>
<NDC11Code>82123-0009-31</NDC11Code>
<ProductNDC>82123-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Propolis Nasal</ProprietaryName>
<NonProprietaryName>Nasal</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20231002</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.015</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-001-01</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-01) > 35 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-01</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091118</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-02</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-02) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-02</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-03</NDCCode>
<PackageDescription>60 BAG in 1 CASE (53877-001-03) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-03</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-04</NDCCode>
<PackageDescription>48 BAG in 1 CASE (53877-001-04) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-04</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-05</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-05) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-05</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-06</NDCCode>
<PackageDescription>36 BAG in 1 CASE (53877-001-06) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-06</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-07</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-07) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-07</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-08</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-001-08) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-08</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-09</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-001-09) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-09</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-10</NDCCode>
<PackageDescription>36 BAG in 1 CASE (53877-001-10) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-10</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-11</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-11) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-11</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-12</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-001-12) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-12</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-13</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-13) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-13</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-14</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-001-14) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-14</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>53877-006-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CASE (53877-006-06) / 3 BAG in 1 BLISTER PACK (53877-006-01) / 1 KIT in 1 BAG (53877-006-02) * 70 mL in 1 BAG * 111 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0006-06</NDC11Code>
<ProductNDC>53877-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imuflex Wb-rp Blood Bag System With Integral Whole Blood Leukocyte Reduction Filter (removing Platelets) 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>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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 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. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature or cooled towards 1-10°C (transport temperature). 1.7. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and a 500mL (nominal capacity 600mL) collection bag containing 70mL Citrate Phosphate Dextrose (CPD) anticoagulant. The Quadruple blood bag set has one integrally attached empty primary bag, one empty satellite bag, and one satellite bag containing 111 mL OPTISOL Red Cell Preservative Solution. 11.2. Blood bag codes ending in A2 are the collection set with an Integral Diversion Blood Sampling Arm for obtaining donor samples 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. Tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-108-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CASE (53877-108-06) / 4 BAG in 1 BLISTER PACK (53877-108-01) / 63 mL in 1 BAG (53877-108-02) </PackageDescription>
<NDC11Code>53877-0108-06</NDC11Code>
<ProductNDC>53877-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) For Collection Of 450ml Of Blood</ProprietaryName>
<NonProprietaryName>Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE</SubstanceName>
<StrengthNumber>2.99; 26.3; 2.22; 31.9; .275</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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 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.</Description>
</NDC>
<NDC>
<NDCCode>53877-109-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CASE (53877-109-06) / 4 BAG in 1 BLISTER PACK (53877-109-01) / 70 mL in 1 BAG (53877-109-02) </PackageDescription>
<NDC11Code>53877-0109-06</NDC11Code>
<ProductNDC>53877-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood With Diversion Blood Sampling Arm 70 Ml Cpda-1</ProprietaryName>
<NonProprietaryName>Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE</SubstanceName>
<StrengthNumber>2.99; 26.3; 2.22; 31.9; .275</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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 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.</Description>
</NDC>
<NDC>
<NDCCode>53877-110-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CASE (53877-110-06) / 5 BAG in 1 BLISTER PACK (53877-110-01) / 70 mL in 1 BAG (53877-110-02) </PackageDescription>
<NDC11Code>53877-0110-06</NDC11Code>
<ProductNDC>53877-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm 70 Ml Cpda-1</ProprietaryName>
<NonProprietaryName>Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE</SubstanceName>
<StrengthNumber>2.99; 26.3; 2.22; 31.9; .275</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</IndicationAndUsage>
<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 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.</Description>
</NDC>
<NDC>
<NDCCode>13537-119-32</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-119-32) > 4 g in 1 TUBE (13537-119-31)</PackageDescription>
<NDC11Code>13537-0119-32</NDC11Code>
<ProductNDC>13537-119</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Couleur Luxe Rouge Amplifier Xp Amplifying Spf 15</ProprietaryName>
<ProprietaryNameSuffix>(dore Chocolat) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.047; .009</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49698-009-01</NDCCode>
<PackageDescription>1 CASE in 1 CARTON (49698-009-01) / 80 g in 1 CASE</PackageDescription>
<NDC11Code>49698-0009-01</NDC11Code>
<ProductNDC>49698-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Asepso Herbal Scented Antiseptic</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>CODAA SWITZERLAND AG</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50269-009-06</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 BOX (50269-009-06) / 2 POUCH in 1 BLISTER PACK / 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>50269-0009-06</NDC11Code>
<ProductNDC>50269-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Midol Complete</ProprietaryName>
<NonProprietaryName>Acetaminophen, Caffeine, Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>JC World Bell Wholesale Co., Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>500; 60; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water-weight gain, 4 headache, 5 backache, 6 muscle aches, 7 fatigue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53206-009-20</NDCCode>
<PackageDescription>20412 kg in 1 TANK (53206-009-20) </PackageDescription>
<NDC11Code>53206-0009-20</NDC11Code>
<ProductNDC>53206-009</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<StartMarketingDate>20191231</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Caldic USA Inc</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-DEC-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>58793-009-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (58793-009-01) </PackageDescription>
<NDC11Code>58793-0009-01</NDC11Code>
<ProductNDC>58793-009</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20161222</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Kreative Organics Private Limited</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>.85</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>22-DEC-16</StartMarketingDatePackage>
<EndMarketingDatePackage>31-JAN-25</EndMarketingDatePackage>
</NDC>
</NDCList>