ALBUTEIN ALBUMIN (HUMAN) 12.5 g/250mL Injection, Solution, 250 mL
by GRIFOLS USA, LLC · 1 BAG in 1 CARTON (68516-5218-1) / 250 mL in 1 BAG (68516-5218-0)
NDC 68516-5218-01
🏷️ FDA NDC (as labeled)
68516-5218-1
billing pads the package segment with a zero
This package
Contains250 mL
Pack sizes2 compare ↓
Also comes in:
250 ml 68516-5218-04
Brand
On market
Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
68516-5218-1
Product NDC
68516-5218
11-digit billing NDC
68516521801
Application #
BLA102478
SPL Set ID
a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945
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
2023-11-15
Route
INTRAVENOUS
Dosage form
INJECTION, SOLUTION
Substance
ALBUMIN HUMAN
GCN Seq No
006330
GCN
25051
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
ALBUTEIN 5% IV SOLUTION
FDB brand name
Albutein
Legend status
F — Federal legend — prescription drug or device
Biologic (Purple Book)
351(a)
Why two NDCs?
The FDA registers this code as 68516-5218-1 — a 5-4-1 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 package segment → 68516-5218-01. 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.
🏭 Manufacturer & labeler
LabelerGRIFOLS USA, LLC
FDA applicationBLA102478 (BLA)
Labeler code68516
First marketedNov 2023
Product typePlasma Derivative
Portfolio52 products on file
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 ALBUTEIN 5% 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.
💬 Questions about ALBUMIN (HUMAN)?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
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.
4 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 |
|---|---|---|---|---|---|---|
| Alburx 12.5 g/250mL 44206-0310-25 | CSL | 1 vial | — | — | FDA listed | — |
| Albutein 12.5 g/250mLthis 68516-5218-01 | GRIFOLS | 250 ml | — | — | FDA listed | — |
| Albutein 12.5 g/250mL 68516-5214-09 | GRIFOLS | 250 ml | — | — | Discontinued | — |
| Albutein 12.5 g/250mL 68516-5219-01 | GRIFOLS | 500 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
🏛️
1978
First FDA approval
Aug 1978
📍
2026
Currently FDA-listed
48 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.
📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
Medicare Part D (outpatient prescription) spending for Albutein — 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 Albutein. 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
$13.6K
Claims incl. refills
48
Beneficiaries
21
Spend / beneficiary
$646.41
Spend / claim
$282.80
💵 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
Male · 55%
Female · 45%
Unknown · 0%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68516-5218-01 You're viewing this | 1 BAG in 1 CARTON (68516-5218-1) / 250 mL in 1 BAG (68516-5218-0) | 2023-11-15 | Active |
| 68516-5218-04 | 4 BAG in 1 CARTON (68516-5218-4) / 250 mL in 1 BAG (68516-5218-0) | 2023-11-15 | Active |
Pack size FAQ
What quantity is in NDC 68516-5218-01?
NDC 68516-5218-01 contains 250 mL — 1 bag in 1 carton / 250 ml in 1 bag.
What NDC number is used to bill for this package of ALBUTEIN ALBUMIN (HUMAN) 12.5 g/250mL Injection, Solution?
Bill NDC 68516-5218-01 — the 11-digit billing format is 68516521801. 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 68516-5218-1, 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: 68516-5218-01, written without dashes as 68516521801. 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 68516-5218-01, the first segment (68516) is the labeler code FDA assigned to GRIFOLS USA, LLC; the middle segment (5218) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 GRIFOLS USA, LLC. 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 250 ml (68516-5218-04). 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?
GRIFOLS USA, LLC 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 ▾
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 ↗
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.