Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
FLEXBUMIN Albumin Human .25 g/mL Solution — NDC 0944-0493-01 (Billing 00944-0493-01)
by Takeda Pharmaceuticals America, Inc. · 12 BAG in 1 CARTON / 50 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.
NDC 00944-0493-01
🏷️ FDA NDC (as labeled)
0944-0493-01
billing pads the labeler segment with a zero
This package
Contains50 mL in 1 bag
Medicaid pays$0.7817 / unit · 12 mo
Per package$469.02 / 600 ml · Medicaid
Pack sizes2 compare ↓
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 0944-0493-01 alone.
- Record
- FDA NDC Directory package listing · Plasma derivative
- Code segments
- 0944 labeler · 0493 product · 01 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 0944049301 5
- Medicaid fills, this package
- 891 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)
0944-0493-01
Product NDC
0944-0493
11-digit billing NDC
00944049301
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 0944-0493-01 — 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 → 00944-0493-01. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Label name FLEXBUMIN 25% IV SOLUTION Ingredient Albumin Human
📖 What it is MedlinePlus · NLM
Albumin (human) injection is used to treat low blood volume (hypovolemia) and low albumin levels in the blood (hypoalbuminemia) caused by bleeding, burns, major injuries or infections, malnutrition, major surgery, and other serious medical problems. It is also used during certain surgeries and medical treatments. Albumin (human) injection is in a class of medications called protein colloids. It works by keeping fluid from leaking out of blood vessels and helps to move important substances through the body.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Albumin Human?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.7817 | $469.02 / 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00944-0493-01 You're viewing this | 12 BAG in 1 CARTON / 50 mL in 1 BAG | 2002-08-09 | — | Active |
| 00944-0493-02 0944-0493-02 Main listing | 6 BAG in 1 CARTON / 100 mL in 1 BAG | 2002-08-09 | — | Active |
This pack accounts for about 26% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 12 bag in 1 carton / 50 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Albuminex .25 g/mL 64208-2512-03 | BPL | 1 vial | — | — | FDA listed | — |
| Flexbumin .25 g/mLthis 00944-0493-01 | Takeda | 50 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
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.
- FDA Purple Book · refreshed Oct 5, 2026
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 3EN9H0M2FX
A salt form of an amino acid derivative used as a solubilizer and stabilizer in liquid and injectable formulations. It helps keep active ingredients dissolved and protected from degradation during storage.
-
UNII 9XTM81VK2B
Sodium caprylate is a salt derived from caprylic acid, a naturally occurring fatty acid. In medicines, it acts as a preservative and antimicrobial agent to help prevent contamination and extend shelf life.
-
UNII LYR4M0NH37
Sodium cation is a positively charged form of the mineral sodium. In medications, it's used as a buffer to help maintain proper pH balance and improve stability of the product.
3 inactive ingredients 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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
- Flexbumin Albumin Human .05 g/mL Injection, Solution NDC 0944-0495-05
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2510-02
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2511-02
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2512-02
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2513-02
- HYQVIA Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase Kit NDC 0944-2514-02
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
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
891
Units reimbursed last 4 qtrs
127.1K
Gross reimbursed last 4 qtrs
$99.3K
Avg / prescription
$111.50
Avg / unit
$0.7817
Latest quarter Q1 2026
124Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 83 Rx Managed care · 808 Rx
State Medicaid map
Units reimbursed · per 100k residents
14.9344
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
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
Age at onset
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 | ✓ 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) | ✓ 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 100 ml (00944-0493-02). 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.
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.