NDC 61953-0004-01 — Flebogamma DIF Immune Globulin (Human) .05

🆔 Identity & classification

FDA NDC (as labeled) 61953-0004-1

Product NDC 61953-0004

11-digit billing NDC 61953000401

NCPDP billing unit ML — per mL (volume)

Application # BLA125077

SPL Set ID 6c2e3e83-43fe-48d2-b6a6-7b78870210b7

Established class (EPC) Human Immunoglobulin G

Mechanism of action Antigen Neutralization

Physiologic effect Passively Acquired Immunity

Chemical class Immunoglobulins

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2006-12-21

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance HUMAN IMMUNOGLOBULIN G

GPI-14 19100020102044

GPI class Flebogamma DIF

GCN Seq No 073513

GCN 37917

HICL code 041762

Ingredient (HICL) Imm Glob G (Igg)/Sorb/Iga 0-50

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W7

Therapeutic class — intermediate (HIC2) Biologicals

HIC3 code W7K

Therapeutic class — specific (HIC3) Antisera

AHFS code 80:04.00.00

AHFS class Antitoxins And Immune Globulins

FDB label name FLEBOGAMMA DIF 5% VIAL

FDB brand name Flebogamma Dif

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 61953-0004-1 — 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 → 61953-0004-01. 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 applicationBLA125077 (BLA)

Labeler code61953

First marketedDec 2006

Product typePlasma Derivative

Portfolio52 products on file

🔎 All NDCs from GRIFOLS USA, LLC

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 FLEBOGAMMA DIF 5% VIAL Ingredient Imm Glob G (Igg)/Sorb/Iga 0-50

📗 Our plain-language guide HelloPharmacist

Think of it as a collection of protective proteins — called antibodies — that healthy donors have built up against many different germs. If your immune system can't make enough of...
What exactly is human immunoglobulin G and why do I need it?
It depends on the specific product your doctor prescribed. The IV versions — like Privigen, Asceniv, Qivigy, and Gammaplex — are infused into a vein, usually every 3 to 4 weeks. Hi...
How is it given, and how often will I need infusions?

📖 Read our full Human Immunoglobulin G guide →

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.

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.

💲 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: 50 mL 100 mL 200 mL 400 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
Flebogamma DIF .05 g/mLthis 61953-0004-01	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

🏛️

2003

First FDA approval

Dec 2003

📍

2026

Currently FDA-listed

23 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

Baygam, Gamastan S/DImmune Globulin (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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
61953-0004-01 You're viewing this	1 VIAL in 1 CARTON (61953-0004-1) / 10 mL in 1 VIAL (61953-0004-6)	2006-12-21	Active
61953-0004-02	1 VIAL in 1 CARTON (61953-0004-2) / 50 mL in 1 VIAL (61953-0004-7)	2006-12-21	Active
61953-0004-03	1 VIAL in 1 CARTON (61953-0004-3) / 100 mL in 1 VIAL (61953-0004-8)	2006-12-21	Active
61953-0004-04	1 VIAL in 1 CARTON (61953-0004-4) / 200 mL in 1 VIAL (61953-0004-9)	2006-12-21	Active
61953-0004-05	1 VIAL in 1 CARTON (61953-0004-5) / 400 mL in 1 VIAL (61953-0004-0)	2006-12-21	Active

Pack size FAQ

What quantity is in NDC 61953-0004-01?

NDC 61953-0004-01 is listed by the FDA — 1 vial in 1 carton / 10 ml in 1 vial.

What NDC number is used to bill for this package of Flebogamma DIF Immune Globulin (Human) .05 g/mL Injection, Solution?

Bill NDC 61953-0004-01 — the 11-digit billing format is 61953000401. 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	— 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)	— 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 61953-0004-1, 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: 61953-0004-01, written without dashes as 61953000401. 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 61953-0004-01, the first segment (61953) is the labeler code FDA assigned to GRIFOLS USA, LLC; the middle segment (0004) 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 4 other package presentations of this same product, including 1 vial (61953-0004-02), 1 vial (61953-0004-03), 1 vial (61953-0004-04). 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

📄 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 Immune Globulin (Human) NDCsSame ingredient 🏭 All GRIFOLS labeler NDCsLabeler code 61953 📚 All Human Immunoglobulin G NDCsDrug class

💊 Related drugs in this class

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

Immun Glob G(Igg)-Ifas/Glycine 00069-1011-02 Immun Glob G(Igg)-Hipp/Maltose 00069-1061-02 Immun Globg(Igg)/Malt/Iga Ov50 00069-6002-01 Rho(D) Immune Globulin 00562-7805-01 Igg/Hyaluronidase,Recombinant 00944-2510-02 Immun Glob G/Gly/Gluc/Iga 0-50 00944-2656-03 Immun Glob G(Igg)/Gly/Iga Ov50 00944-2700-02 Immun Glob G(Igg)/Gly/Iga 0-50 00944-2705-10 Rabies Immune Globulin/Pf 13533-0318-01 Immune Globul G (Igg)/Glycine 13533-0335-04 Tetanus Immune Globulin/Pf 13533-0634-02 Hepatitis B Immune Globulin 13533-0636-01 Immune Globul G/Gly/Iga Avg 46 13533-0800-12 Immune Globulin,Gamma(Igg)Klhw 13533-0810-05 Immun Glob G(Igg)/Pro/Iga 0-50 44206-0436-05

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.