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NDC 00942-9504-10 Sodium Citrate Blood-Pack Units, (PL 146 Plastic) 4 g/100mL Details
Sodium Citrate Blood-Pack Units, (PL 146 Plastic) 4 g/100mL
Sodium Citrate Blood-Pack Units, (PL 146 Plastic) is a INTRAVENOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fenwal, Inc.. The primary component is TRISODIUM CITRATE DIHYDRATE.
Product Information
| NDC | 00942-9504 |
|---|---|
| Product ID | 0942-9504_f2b75651-90cf-4982-9762-76db5f0524d1 |
| Associated GPIs | 83400080102020 |
| GCN Sequence Number | 062434 |
| GCN Sequence Number Description | sodium citrate SOLUTION 4 G/100 ML MISCELL |
| HIC3 | M9J |
| HIC3 Description | CITRATES AS ANTICOAGULANTS |
| GCN | 98210 |
| HICL Sequence Number | 000537 |
| HICL Sequence Number Description | SODIUM CITRATE |
| Brand/Generic | Generic |
| Proprietary Name | Sodium Citrate Blood-Pack Units, (PL 146 Plastic) |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Anticoagulant Sodium Citrate Solution |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | g/100mL |
| Substance Name | TRISODIUM CITRATE DIHYDRATE |
| Labeler Name | Fenwal, Inc. |
| Pharmaceutical Class | Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | BN770923 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00942-9504-10 (00942950410)
| NDC Package Code | 0942-9504-10 |
|---|---|
| Billing NDC | 00942950410 |
| Package | 500 mL in 1 BAG (0942-9504-10) |
| Marketing Start Date | 2007-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ac8971a9-36d0-43c9-9121-ba5e58c28bed Details
Anticoagulant Sodium Citrate Solution USP
PACKAGE/LABEL DISPLAY PANEL
CAUTION–DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE
THE OVERWRAP IS A MOISTURE BARRIER
THE INNER BAG MAINTAINS STERILITY OF THE PRODUCT
STORE AT CONTROLLED ROOM TEMPERATURE.
CODE 4B7889Q
NDC 0942-9504-10
500 mL
Fenwal™
Anticoagulant Sodium Citrate Solution USP
Rx only
EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID
STERILE
NONPYROGENIC
FOR USE WITH CYTAPHERESIS DEVICE ONLY
NOT FOR DIRECT INTRAVENOUS INFUSION
SINGLE USE CONTAINER
DISCARD UNUSED PORTION
DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED
AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY
IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED
MANUFACTURED BY:
BAXTER HEALTHCARE CORPORATION
DEERFIELD, IL 60015 USA
MANUFACTURED FOR:
FENWAL, INC.
LAKE ZURICH, IL 60047 USA
MADE IN USA
07-25-58-000
PL 146 PLASTIC
INGREDIENTS AND APPEARANCE
| SODIUM CITRATE BLOOD-PACK UNITS, (PL 146 PLASTIC)
anticoagulant sodium citrate solution solution |
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| Labeler - Fenwal, Inc. (794519020) |
| Registrant - Fenwal, Inc. (794519020) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Baxter Healthcare Corporation | 059140764 | MANUFACTURE(0942-9504) | |