Anticoagulant Citrate Dextrose A

Manufacturer
Citra Labs LLC
Effective date
2023-02-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 20:47:16

Label at a glance#

ProductAnticoagulant Citrate Dextrose A
Active ingredientDEXTROSE MONOHYDRATE, ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE
Label structure14 sections

Indications and uses

Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

Dosage and administration

Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A), is a sterile, non-pyrogenic solution of citric acid, sodium citrate, and dextrose, in water for injection. Each 10 mL of solution contains:

Citric Acid, anhydrous, USP0.073 g
Sodium Citrate, dihydrate, USP0.220 g
Dextrose, monohydrate, USP0.245 g
Water for Injection, USPq.s.
pH: 4.5 – 5.5

single usesingle use Single patient use only, on a single occasion.

Clinical Pharmacology

CLINICAL PHARMACOLOGY SECTION

ACD-A acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium, thus making calcium unavailable to the coagulation system.

Indications and Usage

INDICATIONS & USAGE SECTION

Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

Contraindications

CONTRAINDICATIONS SECTION

NOT FOR DIRECT INTRAVENOUS INFUSION

Warnings

WARNINGS SECTION

NOT FOR DIRECT INTRAVENOUS INFUSION

Precautions

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

  • Aseptic technique must be maintained at all times.
  • ACD-A solution is a clear and colorless solution. If the product shows any cloudiness or turbidity, the product should be discarded.
  • The closure system provides a biological barrier and should be intact – discard product if system is compromised.

Information for Patients

INFORMATION FOR PATIENTS SECTION

None.

Carcinogenesis, mutagenesis, impairment of fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A.

Pregnancy

PREGNANCY SECTION

Long-term studies in animals have not been performed to evaluate the effects of ACD- A on pregnant women.

Pediatric Use

PEDIATRIC USE SECTION

The safety and effectiveness of ACD-A in children have not been established.

Adverse Reactions

ADVERSE REACTIONS SECTION

Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP).

Overdosage

OVERDOSAGE SECTION

Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP systems in production of platelet rich plasma (PRP).

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

Rx Only

SPL UNCLASSIFIED SECTION

Caution: Federal Law (US) restricts this devise to sale by or on the order of a Physician.

How Supplied

HOW SUPPLIED SECTION

Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A)

 REFSIZECASE
 PN 9350-1030 mL10 Vials/Case
 PN 9350-2530 mL25 Vials/Case

STORAGE AND HANDLING SECTION

It is recommended that the product be stored at ambient room temperature, 24 °C (75 °F); however, the product can be stored between 15 °C (59 °F) and 30 °C (86 °F). Protect from freezing and exposure to excessive heat should be minimized.

SPL UNCLASSIFIED SECTION

Manufactured & Distributed by:
CitraLabs™
55 Messina Drive, Braintree, MA 02184
Phone Number: 1-800-299-3411

Authorized Representative:
Biomet Global Supply Chain Center B.V.
Hazeldonk 6530
4836 LD Breda
The Netherlands

Principal Display PanelPrincipal Display Panel

PRINCIPAL DISPLAY PANEL - 10 Vial Case Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C E 0044

ACD-A

Anticoagulant Citrate Dextrose Solution,

10 Vials / Case    Solution A, U.S.P., ACD-A, 30 mL

REF PN 9350-10

WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION

Used as an anticoagulant in the extracorporeal blood processing with
Autologous PRP Systems in production of platelet rich plasma (PRP).
Refer to PRP Systems manufacturer's Directions for Use.

Manufactured & Distributed by:

CitraLabs
A Biomet Inc. Company.

Citra Labs, LLC.
55 Messina Drive, Braintree, MA 02184
1-800-299-3411

EC REP

Authorized Representative:
Biomet Global Supply Chain Center B.V.
Hazeldonk 6530
4836 LD Breda
The Netherlands

symbolssymbols

STERILE • NON-PYROGENIC
Composition per 10 mL of Solution:
Citric Acid, (Anhydrous), U.S.P. 0.073 g.
Sodium Citrate, (Dihydrate), U.S.P. 0.220 g.
Dextrose, (Monohydrate), U.S.P. 0.245 g.
CAUTION: Single Procedure Use-Discard Unused Portion
Do Not Use Unless Solution is Clear and Seal is Intact.
Store Between 15 °C - 30 °C (59 °F - 86 °F).
RX Only:

EXP DATE

LOT

LA9350-10B 01/20

labellabel

PRINCIPAL DISPLAY PANEL - 25 Vial Case Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C E 0044

ACD-A

Anticoagulant Citrate Dextrose Solution,

25 Vials / Case    Solution A, U.S.P., ACD-A, 30 mL

REF PN 9350-25

WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION

Used as an anticoagulant in the extracorporeal blood processing with
Autologous PRP Systems in production of platelet rich plasma (PRP).
Refer to PRP Systems manufacturer's Directions for Use.

Manufactured & Distributed by:

CitraLabs
A Biomet Inc. Company.

Citra Labs, LLC.
55 Messina Drive, Braintree, MA 02184
1-800-299-3411

EC REP

Authorized Representative:
Biomet Global Supply Chain Center B.V.
Hazeldonk 6530
4836 LD Breda
The Netherlands

symbolssymbols

STERILE • NON-PYROGENIC
Composition per 10 mL of Solution:
Citric Acid, (Anhydrous), U.S.P. 0.073 g.
Sodium Citrate, (Dihydrate), U.S.P. 0.220 g.
Dextrose, (Monohydrate), U.S.P. 0.245 g.
CAUTION: Single Procedure Use-Discard Unused Portion
Do Not Use Unless Solution is Clear and Seal is Intact.
Store Between 15 °C - 30 °C (59 °F - 86 °F).
RX Only:

EXP DATE

LOT

LA9350-25 01/20

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23731-6051-1Anticoagulant Citrate Dextrose A10 in 1 CASESOLUTION105
23731-6051-2Anticoagulant Citrate Dextrose A25 in 1 CASESOLUTION255
23731-6051-3Anticoagulant Citrate Dextrose A30 mL in 1 VIAL, SINGLE-USESOLUTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23731-6051ANTICOAGULANT CITRATE DEXTROSE A (ANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [CITRA LABS LLC]5Current NDC, Legacy NDC, 3 package rows20230215_5bcd261e-ebba-4ecb-af22-e5aaeb04499b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23731-6051-5ML - Milliliter23731-6051fa7599c0-4738-42b4-b126-ddd505bb062812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSL2
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083G2
Trisodium Citrate DihydrateACTIVE INGREDIENTB22547B95K2
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSL2
Anhydrous DextroseACTIVE MOIETY5SL0G7R0OK2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23731-605123731-6051-3, 23731-6051-1, 23731-6051-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020037-001VOLTARENDICLOFENAC SODIUM0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020037-001AT174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020037-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N020037-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020037-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020037-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020037-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N020037-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020037-001AT1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticoagulant Citrate Dextrose AANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATECitra Labs LLC5bcd261e-ebba-4ecb-af22-e5aaeb04499b2023-02-14Warnings, Adverse reactionsExact identifier
ndc (package): 23731-6051-2
ndc (package): 23731-6051-1
ndc (package): 23731-6051-3
ndc (product): 23731-6051
ndc11 (package): 23731605102
ndc11 (package): 23731605101
ndc11 (package): 23731605103
spl id: 9a133b17-0377-431f-b839-3e090fdabd78
spl set id: 5bcd261e-ebba-4ecb-af22-e5aaeb04499b