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InterSol Platelet Additive 3 452 mg/100mL; 442 mg/100mL; 318 mg/100mL; 305 mg/100mL; 93 mg/100mL Solution, 500 mL — NDC 00942-9602-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

InterSol Platelet Additive 3 452 mg/100mL; 442 mg/100mL; 318 mg/100mL; 305 mg/100mL; 93 mg/100mL Solution, 500 mL — NDC 0942-9602-12 (Billing 00942-9602-12)

by Fenwal, Inc. · 500 mL in 1 BAG

This is a package of 500 mL of InterSol Platelet Additive 3 452 mg/100mL; 442 mg/100mL; 318 mg/100mL; 305 mg/100mL; 93 mg/100mL Solution from Fenwal, Inc., marketed since Jun 2019 and currently FDA-listed. It is this product's only package size.

NDC 00942-9602-12
🏷️ FDA NDC (as labeled) 0942-9602-12 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0942-9602-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0942 labeler · 9602 product · 12 package
Package marketed since
Jun 5, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0942960212 4
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0942-9602-12
Product NDC 0942-9602
11-digit billing NDC 00942960212
UNII 451W47IQ8X, 4550K0SC9B, B22547B95K, GR686LBA74, 593YOG76RN
Application # BN080041
SPL Set ID a00c4a93-cde2-4753-81f7-0d6fee9fb690
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-05
Route INTRAVENOUS
Dosage form SOLUTION
Substance SODIUM CHLORIDE; SODIUM ACETATE; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Why two NDCs? The FDA registers this code as 0942-9602-12 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00942-9602-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00942-9602-12 You're viewing this Main listing 500 mL in 1 BAG 2019-06-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
InterSol 452 mg/100mL; 442 mg/100mL; 318 mg/100mL; 305 mg/100mL; 93 mg/100mLthis 00942-9602-12 Fenwal, 500 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFenwal, Inc.
FDA applicationBN080041 (NDA)
Labeler code00942
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio41 products on file

More NDCs from Fenwal, Inc. labeler code 00942

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

Rx only Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.

Definition of "Controlled Room Temperature": "A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15°C and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours ...

The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations." Reference: United States Pharmacopeia, General Notices. United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville, MD.

Dispose of waste in appropriate biohazard container or according to local regulatory requirements. Indications and Usage: InterSol solution is an isotonic solution designed to replace a proportion of the plasma used in the storage of leukoreduced apheresis platelets under standard blood banking conditions. There is no direct therapeutic effect to be expected from the formulation.

The solution should never be infused directly into a patient. InterSol platelets are leukocyte-reduced apheresis platelet concentrates that are stored in a mix of 65% InterSol and 35% plasma, nominal. InterSol platelets prepared within the ranges described in the apheresis system Operator's Manuals may be stored for up to 5 days at 20-24°C, with continuous agitation.

⏱️ Dosage and Administration 38 words ▾

Dosage and Administration: InterSol solution is to be used with the AMICUS Separator System or the TRIMA ACCEL system. For full instructions on the use of InterSol solution, see the Operator's Manual for the respective platelet collection system.

💊 Dosage Forms and Strengths 69 words ▾

Dosage Forms and Strengths: InterSol solution is provided as a 500 mL sterile and non-pyrogenic solution in a non-PVC plastic container with a sterile and non-pyrogenic fluid path. Each 100 mL contains 305 mg Dibasic Sodium Phosphate, Anhydrous, USP; 93 mg Monobasic Sodium Phosphate, Monohydrate, USP; 318 mg Sodium Citrate, Dihydrate, USP; 442 mg Sodium Acetate, Trihydrate, USP; 452 mg Sodium Chloride, USP; Water for Injection, USP quantity sufficient.

⛔ Contraindications 41 words ▾

Contraindications: InterSol solution is added to apheresis-derived leukoreduced platelet concentrates after the apheresis procedure is complete. It is not for direct intravenous infusion. There are no known contraindications associated with the use of InterSol solution for the preparation of InterSol platelets.

⚠️ Warnings and Cautions 86 words ▾

Warnings and Precautions: • InterSol solution is NOT FOR DIRECT INTRAVENOUS INFUSION. • Do not use if particulate matter is present or if the solution is cloudy. • Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. • Do not vent. • Do not reuse. Discard unused or partially used InterSol solution. • Protect from sharp objects. • Verify that the InterSol solution has been securely attached to the PAS Connector line to avoid disconnection and leaks.

🤒 Adverse Reactions 40 words ▾

Adverse Reactions: InterSol solution is added to leukoreduced platelet concentrates after the apheresis procedure is complete. It is not for direct intravenous infusion. InterSol solution is not expected to cause adverse events other than those normally associated with platelet transfusion.

🆘 Overdosage 20 words ▾

Overdosage: InterSol solution is used as a storage solution for platelet concentrates and it is not for direct intravenous infusion.

🧬 Clinical Pharmacology 27 words ▾

Clinical Pharmacology: InterSol solution is used as a storage solution for platelet concentrates and it is not for direct intravenous infusion. This solution has no pharmacological effect.

📦 How Supplied / Storage and Handling 97 words ▾

How Supplied/Storage and Handling : 500 mL sterile solution in a non-PVC plastic container with a sterile, non-pyrogenic fluid path. The InterSol solution container is supplied in a vented plastic overwrap covering that serves as a dust cover for the container. The dust cover is not a sterility barrier and is not an element that defines the expiration date of the InterSol product.

TRIMA ACCEL is a trademarks of Terumo BCT, Inc. © 2018 Fresenius Kabi AG. All rights reserved. Fresenius Kabi AG 61346 Bad Homburg / Germany Tel.: +49 (0) 61 72 / 686-0 www.fresenius-kabi.com symbols

📋 Description 92 words ▾

Description: InterSol solution is an isotonic solution designed to replace a proportion of the plasma used in the storage of platelets. The solution contains constituents that are naturally occurring components present in many cellular systems: sodium acetate as a nutrient, sodium citrate to prevent platelet clumping and activation, sodium phosphate for buffering and sodium chloride for osmolarity. InterSol solution does not have a pharmacological effect in vivo, but rather acts to provide the appropriate environment and nutrients in lieu of a portion of the plasma normally used for the storage of platelets.

🔬 Clinical Studies ~3 min read ▾

Clinical Studies: In Vitro Biochemical and Functional Evaluations AMICUS-derived, leukoreduced platelets InterSol platelet concentrates (n=70) prepared using the AMICUS separator and stored for 5 days showed a median and mean pH value on Day 5 of 7.2 and 7.2 ± 0.1 (range: 6.9-7.5), respectively, with a lower non-parametric 95%/95% tolerance limit of 6.9. Supplemental in vitro assessments of InterSol platelets and AMICUS-derived leukoreduced platelets stored in 100% plasma are presented in Table 2. InterSol platelets irradiated (n=18) at either 2500 or 2800 cGray (dependent on site procedures) were compared to non-irradiated InterSol platelets.

At the end of storage on Day 5 the platelet yields of the irradiated products were concentrated between 2.5 x 10 11 to 3.5 x 10 11 and included one product with a yield less than2.5 x 10 11 and two products with yields greater than 3.5 x 10 11 . In vitro testing is not predictive of in vivo performance, which was not evaluated. Summary statistics are presented in Table 3.

In Vivo Recovery and Survival in Healthy Subjects AMICUS-derived, leukoreduced platelets In vivo evaluation of InterSol platelets at Day 5 (n=33) compared to a fresh platelet control resulted in a mean percent recovery of 46.4 ± 11.9 percent and 58.0 ± 10.7 percent and mean survival of 5.7 ± 1.4 days and 8.0 ± 1.4 days, respectively. The in vivo data collected were used to calculate the upper limit of a two-sided 95% confidence interval of the mean percent recovery of the algebraic expression (0.66 x Fresh – 5 Day), and of the mean percent survival (days) of the algebraic expression (0.58 x Fresh – 5 Day).

The upper bound of the two-sided 95% confidence intervals for recovery and survival on Day 5 was –4.6 and –0.6 respectively and met the requirement of less than 0. Post-Market Transfusion-Related Adverse Events (AE) Study AMICUS-derived, leukoreduced platelets An open label, non-randomized, retrospective medical record review study was performed in 6 centers to demonstrate that the overall rate of transfusion-related AEs in patients receiving InterSol Platelet transfusions was not more than double the rate in patients receiving apheresis platelets stored in 100% plasma (Plasma Platelets).

The study categorized adverse transfusion reactions according to the definitions outlined by the Biovigilance Component of the National Healthcare Safety Network (NHSN) System. All sites that participated were required to have systems in place to observe transfusion-related AEs and to record when no transfusion-related AE was observed. An independent Clinical Events Committee (CEC) blinded to platelet type and study site adjudicated the reported events.

Patients were prescribed platelet transfusions per each site’s standard practice. The type of platelet unit the patient received was based on the site’s inventory at the time the transfusion was ordered. Site personnel observed the platelet transfusion recipient following their standard procedures.

Signs and symptoms of a potential transfusion-related reaction were noted using existing reporting systems. A total of 14,005 transfusions from 6 study sites were included in the final analysis. A total of 4,160 InterSol Platelet transfusions were given to a total of 1,444 patients, and 9,845 Plasma Platelet transfusions were given to 2,202 patients.

There were 165 CEC-adjudicated adverse reactions reported. Of those, 23 events were associated with InterSol Platelets and 142 events were associated with Plasma Platelets. Overall, 1.13% of all transfusions resulted in an AE.

The percentage of InterSol Platelet transfusions which led to AEs was 0.55%, while 1.37% of Plasma Platelet transfusions resulted in AEs. The 97.5% upper confidence limit for the relative risk of transfusion-related AE associated with InterSol Platelets relative to Plasma Platelets was 0.66, indicating that the study objective of ruling out a doubling of transfusion-related AEs for InterSol vs. Plasma Platelets was met.

T… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 20 words ▾

Drug Abuse / Dependence: InterSol solution is used as a storage solution for platelet concentrates and has no pharmacological effect.

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 6b7880lbl

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fenwal, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fenwal, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00942-9601-12 · Fenwal, 00942-9603-12 · Fenwal, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.