NDC 76125-0790-05 — Albuked Albumin (Human) 2.5 g/50mL Solution

🆔 Identity & classification

FDA NDC (as labeled) 76125-790-05

Product NDC 76125-790

11-digit billing NDC 76125079005

Application # BLA101138

SPL Set ID fac1e3bd-5b30-f251-c5ae-2226caecf51d

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 1976-08-26

Route INTRAVENOUS

Dosage form SOLUTION

Substance ALBUMIN HUMAN

GPI-14 85400010002010

GPI class Albuked 5

GCN Seq No 006332

GCN 25061

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 ALBUKED-5 VIAL

FDB brand name Albuked-5

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 76125-790-05 — a 5-3-2 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 product segment → 76125-0790-05. 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.

🏭 Manufacturer & labeler

LabelerKEDRION BIOPHARMA, INC.

FDA applicationBLA101138 (BLA)

Labeler code76125

First marketedAug 1976

Product typePlasma Derivative

Portfolio23 products on file

🔎 All NDCs from KEDRION BIOPHARMA, INC.

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.

🩺 Clinical

Label name ALBUKED-5 VIAL 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

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 4460NBV53F
N-acetyl-DL-tryptophan is a modified form of the amino acid tryptophan. In medications, it typically serves as a buffering agent or pH regulator to maintain the product's chemical stability and effectiveness.
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 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.

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.

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.

💲 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	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.

Try another pack size: 250 mL

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Albuked 2.5 g/50mLthis 76125-0790-05	KEDRION	1 vial	—	—	FDA listed	—
Plasbumin 2.5 g/50mL 13533-0690-20	GRIFOLS	1 vial	—	—	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

🏛️

1942

First FDA approval

Oct 1942

📍

2026

Currently FDA-listed

84 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.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5Albumin (Human) Albumin (Human) Albuminar, Albuminar-20, Albuminar-25, Albuminar-5Albumin (Human) AlbuminexAlbumin (Human)-kjda AlburxAlbumin (Human) AlbuteinAlbumin (Human) Buminate, FlexbuminAlbumin (Human) Human Albumin GrifolsAlbumin (Human) KedbuminAlbumin (Human)

🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

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.

💊 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.

1 vial76125-0790-25 13 Rx · $635

1 vial this page76125-0790-05 No Medicaid data

Drug total (last 4 qtrs): 13 Rx · 3,250 units · $635 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 (matched by generic name) — 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. CMS lists 5 products for this generic; we show the highest-spend one. 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
76125-0790-05 You're viewing this	1 VIAL in 1 CARTON (76125-790-05) / 50 mL in 1 VIAL (76125-790-06)	1976-08-26	Active
76125-0790-25	1 VIAL in 1 CARTON (76125-790-25) / 250 mL in 1 VIAL (76125-790-26)	1976-08-26	Active

Pack size FAQ

What quantity is in NDC 76125-0790-05?

NDC 76125-0790-05 is listed by the FDA — 1 vial in 1 carton / 50 ml in 1 vial.

What NDC number is used to bill for this package of Albuked Albumin (Human) 2.5 g/50mL Solution?

Bill NDC 76125-0790-05 — the 11-digit billing format is 76125079005. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	— 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 FDA registers it as 76125-790-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76125-0790-05, written without dashes as 76125079005. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 76125-0790-05, the first segment (76125) is the labeler code FDA assigned to KEDRION BIOPHARMA, INC.; the middle segment (0790) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.

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 KEDRION BIOPHARMA, 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 1 vial (76125-0790-25). 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?

KEDRION BIOPHARMA, 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.

📄 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 ↗

🔗 Related NDC lookups

🧪 All Albumin (Human) NDCsSame ingredient 🏭 All KEDRION labeler NDCsLabeler code 76125 📚 All Human Serum Albumin NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Plasma Proteins.

Antithrombin Iii (Plasma Der) 13533-0602-50 Plasma Protein Fraction 13533-0613-20 Albumin Human-Kjda 64208-2510-01 Plasma Human, Blood Group A 68982-0952-01 Plasma Human, Blood Group B 68982-0953-01 Plasma Human, Blood Group Ab 68982-0954-01 Plasma Human, Blood Group O 68982-0955-01 Plasminogen, Human-Tvmh 70573-0099-02

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.