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FLEXBUMIN Albumin Human .25 g/mL Solution — NDC 0944-0493-02 (Billing 00944-0493-02)

by Takeda Pharmaceuticals America, Inc. · 6 BAG in 1 CARTON / 100 mL in 1 BAG

This is a package of FLEXBUMIN Albumin Human .25 g/mL Solution from Takeda Pharmaceuticals America, Inc., marketed since Aug 2002 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00944-0493-02
🏷️ FDA NDC (as labeled) 0944-0493-02 billing pads the labeler segment with a zero
This package
Contains100 mL in 1 bag Medicaid pays$0.9914 / unit · 12 mo Per package$594.84 / 600 ml · Medicaid Pack sizes2 compare ↓
Main listing for product 0944-0493 · Also comes in: 50 ml 0944-0493-01
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 0944-0493-02 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
0944 labeler · 0493 product · 02 package
Package marketed since
Aug 9, 2002
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0944049302 2
Medicaid fills, this package
2,569 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0944-0493-02
Product NDC 0944-0493
11-digit billing NDC 00944049302
NCPDP billing unit ML — per mL (volume)
Application # BLA101452
SPL Set ID 176823b1-a331-44a1-8344-87a8ff7a8f9a
Established class (EPC) Human Serum Albumin
Mechanism of action Osmotic Activity
Physiologic effect Increased Intravascular Volume; Increased Oncotic Pressure
Chemical class Serum Albumin
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-08-09
Route INTRAVENOUS
Dosage form SOLUTION
Substance ALBUMIN HUMAN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 85400010002015
GPI class Flexbumin
GCN Seq No 006329
GCN 25050
HICL code 002728
Ingredient (HICL) Albumin Human
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0B
Therapeutic class — specific (HIC3) Plasma Proteins
AHFS code 16:00.00.00
AHFS class Blood Derivatives
FDB label name FLEXBUMIN 25% IV SOLUTION
FDB brand name Flexbumin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006329
  • GCN: 25050
  • GPI-14 (Medi-Span): 85400010002015
  • HICL (First Databank): 002728
  • AHFS class code: 16:00.00.00
Why two NDCs? The FDA registers this code as 0944-0493-02 — 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 → 00944-0493-02. 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

Label name FLEXBUMIN 25% IV SOLUTION Ingredient Albumin Human

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 $0.9914 $594.84 / 600 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
00944-0493-01 0944-0493-01 12 BAG in 1 CARTON / 50 mL in 1 BAG 2002-08-09 — Active
00944-0493-02 You're viewing this Main listing 6 BAG in 1 CARTON / 100 mL in 1 BAG 2002-08-09 — Active

In Medicaid, this is the most-dispensed pack of this product — about 74% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 6 bag in 1 carton / 100 ml in 1 bag.
What NDC number is used to bill for this package of FLEXBUMIN Albumin Human .25 g/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Albuminex .25 g/mL 64208-2512-03 BPL 1 vial — — FDA listed —
Flexbumin .25 g/mLthis 00944-0493-02 Takeda 100 ml — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
1954
First FDA approval
Mar 1954
📍
2026
Currently FDA-listed
72 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerTakeda Pharmaceuticals America, Inc.
FDA applicationBLA101452 (BLA)
Labeler code00944
First marketedAug 2002
Product typePlasma Derivative
Portfolio154 products on file

More NDCs from Takeda Pharmaceuticals America, Inc. labeler code 00944

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 FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.6K
Units reimbursed last 4 qtrs
416.9K
Gross reimbursed last 4 qtrs
$413.3K
Avg / prescription
$160.89
Avg / unit
$0.9914
Latest quarter Q1 2026
456Rx
Fee-for-service vs managed care ⓘ
25% FFS 75% MCO
Fee-for-service · 639 Rx Managed care · 1,930 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 26,200 units · 1,334 per 100k residents ID Montana: no data reported MT North Dakota: 20,000 units · 2,554 per 100k residents ND Minnesota: 19,100 units · 333 per 100k residents MN Wisconsin: no data reported WI Michigan: 5,620 units · 56.0 per 100k residents MI New York: 2,100 units · 10.7 per 100k residents NY Vermont: no data reported VT New Hampshire: 9,700 units · 692 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 8,150 units · 254 per 100k residents IA Illinois: 41,600 units · 332 per 100k residents IL Indiana: no data reported IN Ohio: 25,150 units · 213 per 100k residents OH Pennsylvania: 42,700 units · 329 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 55,050 units · 141 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 1,600 units · 80.9 per 100k residents NE Missouri: no data reported MO Kentucky: 2,150 units · 47.5 per 100k residents KY West Virginia: no data reported WV Virginia: 14,650 units · 168 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 46,750 units · 2,211 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 24,200 units · 340 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 13,850 units · 1,343 per 100k residents DE Oklahoma: 10,600 units · 262 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 47,750 units · 211 per 100k residents FL
Units reimbursed · per 100k residents
10.72,554
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 North Dakota 2,554 /100k
2 New Mexico 2,211 /100k
3 Delaware 1,343 /100k
4 Idaho 1,334 /100k
5 New Hampshire 692 /100k
6 Tennessee 340 /100k
7 Minnesota 333 /100k
8 Illinois 332 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 ml this page00944-0493-02 2,569 Rx · $413,329
50 ml00944-0493-01 891 Rx · $99,348
Drug total (last 4 qtrs): 3,460 Rx · 544,004 units · $512,676 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Flexbumin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Flexbumin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$28.8K
Claims incl. refills
13
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$2,219.02
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Albumin Human — the ingredient across all brands.

Top reported reactions

Renal Failure391
Pyrexia328
Pain319
Dyspnoea278
Pneumonia273
Injury270
Hypotension264

Age at onset

Neonate37
Infant16
Child36
Adolescent29
Adult486
Elderly417

Reporter sex

0 reports

Serious outcomes

Hospitalization2,418
Life-threatening941
Disabling143
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 603 142
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) ✓ Available
“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 Takeda Pharmaceuticals America, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 ml (00944-0493-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Takeda Pharmaceuticals America, 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.
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.
← 00942-9605-01 · Fenwal, 00944-0495-05 · Takeda →
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.