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NDC 63323-0505-74 Sodium Citrate Blood 4 g/100mL Details
Sodium Citrate Blood 4 g/100mL
Sodium Citrate Blood is a INTRAVENOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is TRISODIUM CITRATE DIHYDRATE.
Product Information
| NDC | 63323-0505 |
|---|---|
| Product ID | 63323-505_c4751431-5792-4fad-a13d-887e2e402907 |
| 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 |
| Proprietary Name Suffix | Pack Units, (PL 146 Plastic) |
| 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 | Fresenius Kabi USA, LLC |
| 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 | 2022-12-31 |
Package
Package Images
NDC 63323-0505-74 (63323050574)
| NDC Package Code | 63323-505-74 |
|---|---|
| Billing NDC | 63323050574 |
| Package | 250 mL in 1 BAG (63323-505-74) |
| Marketing Start Date | 2014-09-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ccec1a48-d2f4-4130-93d9-d68502321b1d Details
Anticoagulant Sodium Citrate Solution USP
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 63323-505-74
FUM 4092 1x 250mL
Fresenius Kabi Rx only
freeflex
Anticoagulant Sodium Citrate Solution, USP
EACH 100 mL CONTAINS 4 g SODIUM CITRATE
(DIHYDRATE) USP pH ADJUSTED WITH CITRIC ACID
STERILIZED USING STEAM STERILE FLUID PATH
NONPYROGENIC FOR USE WITH CYTAPHERESIS
DEVICE ONLY
NOT FOR DIRECT INTRAVENOUS INFUSION
DO NOT REUSE DO NOT VENT DISCARD UNUSED
PORTION DO NOT USE UNLESS SOLUTION IS
CLEAR DO NOT USE IF PRODUCT STERILE BARRIER
SYSTEM IS COMPROMISED AFTER REMOVING
OVERWRAP CHECK FOR MINUTE LEAKS BY
SQUEEZING INNER BAG FIRMLY IF LEAKS ARE
FOUND DISCARD SOLUTION AS STERILITY MAY BE
IMPAIRED REMOVE RED TAB FOR PRODUCT USE
DO NOT USE IF TABS ARE DAMAGED
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
PROTECT FROM FREEZING. AVOID EXCESSIVE HEAT
MANUFACTURING FACILITY/
MANUFACTURED BY
FRESENIUS KABI NORGE AS
NO-1753 HALDEN, NORWAY
MADE IN NO
MANUFACTURER
FRESENIUS KABI AG
61346 BAD HOMBURG,
GERMANY
TEL.: +49 (0)6172 686 0
www.fresenius-kabi.com
FUM 4092 01-69-19-001
INGREDIENTS AND APPEARANCE
| SODIUM CITRATE BLOOD
PACK UNITS, (PL 146 PLASTIC)
anticoagulant sodium citrate solution solution |
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| Labeler - Fresenius Kabi USA, LLC (608775388) |
| Registrant - Fresenius Kabi USA, LLC (608775388) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Fresenius Kabi Norge AS | 731170932 | MANUFACTURE(63323-505) | |