Home › NDC Lookup › Ingredients › Immune Globulin › 68982-0840-05
🧴image loading
(from DailyMed)

Octagam Immune Globulin (Human) 50 mg/mL Solution, 500 mL — NDC 68982-840-05 (Billing 68982-0840-05)

by Octapharma USA Inc · 500 mL in 1 BOTTLE, GLASS

This is a package of 500 mL of Octagam Immune Globulin (Human) 50 mg/mL Solution from Octapharma USA Inc, marketed since May 2004 and currently FDA-listed.

NDC 68982-0840-05
🏷️ FDA NDC (as labeled) 68982-840-05 billing pads the product segment with a zero
This package
Contains500 mL Pack sizes5 compare ↓
Product page 68982-0840-04 Also comes in: 20 ml 68982-840-01 50 ml 68982-840-02 100 ml 68982-840-03 200 ml 68982-840-04
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 68982-840-05 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
68982 labeler · 840 product · 05 package
Package marketed since
May 21, 2004
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
500 mL per package
Barcode (UPC-A, from the NDC)
3 6898284005 3
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68982-840-05
Product NDC 68982-840
11-digit billing NDC 68982084005
NCPDP billing unit ML — per mL (volume)
Application # BLA125062
SPL Set ID 1ceaed06-d43c-a23d-a4e0-dce0de4ad7f0
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 2004-05-21
Route INTRAVENOUS
Dosage form SOLUTION
Substance HUMAN IMMUNOGLOBULIN G
Biologic (Purple Book) 351(a)

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

GPI-14 19100020102030
GPI class Octagam
GCN Seq No 073515
GCN 37919
HICL code 041764
Ingredient (HICL) Immun Globg(Igg)/Malt/Iga Ov50
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 OCTAGAM 5% VIAL
FDB brand name Octagam
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073515
  • GCN: 37919
  • GPI-14 (Medi-Span): 19100020102030
  • HICL (First Databank): 041764
  • AHFS class code: 80:04.00.00
Why two NDCs? The FDA registers this code as 68982-840-05 — 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 → 68982-0840-05. 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.

Clinical

Label name OCTAGAM 5% VIAL Ingredient Immun Globg(Igg)/Malt/Iga Ov50
📗 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 →
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 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.
Medicare Part B allowsASP · J1568 $47.056 / J1568 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)68982-840-05
11-digit billing NDC68982-0840-05
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1568
DescriptorINJECTION, IMMUNE GLOBULIN, (OCTAGAM), INTRAVENOUS, NON-LYOPHILIZED (E.G. LIQUID), 500 MG
Billing units / pkg0.1 units
How the units are derivedThis package is 500 ML; the HCPCS unit is 500 MG, so one package = 0.1 billing units.
Medicare Part B spend (2026 (Q1))$60,648,107 · 18,321 claims · $3,310.31 per claim (all NDCs under J1568)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68982-0840-01 68982-840-01 20 mL in 1 BOTTLE, GLASS 2004-05-21 — Active
68982-0840-02 68982-840-02 50 mL in 1 BOTTLE, GLASS 2004-05-21 — Active
68982-0840-03 68982-840-03 100 mL in 1 BOTTLE, GLASS 2004-05-21 — Active
68982-0840-04 68982-840-04 Main listing 200 mL in 1 BOTTLE, GLASS 2004-05-21 — Active
68982-0840-05 You're viewing this 500 mL in 1 BOTTLE, GLASS 2004-05-21 — Active

You're viewing the largest of 5 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 200 ml pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 500 mL — 500 ml in 1 bottle, glass.
How does this package differ from NDC 68982-0840-01?
Both are Octagam Immune Globulin (Human) 50 mg/mL Solution — the drug itself is identical. This page's package is the 500 mL one, while NDC 68982-0840-01 is the 20 ml package.
What NDC number is used to bill for this package of Octagam Immune Globulin (Human) 50 mg/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
Octagam Immune Globulin (Human) 50 mg/mLthis 68982-0840-05 Octapharma 500 ml — — FDA listed —
Octagam Immune Globulin (Human) 50 mg/mL 00069-8425-01 Pfizer 50 ml — — FDA listed —
Octagam Immune Globulin (Human) 50 mg/mL 00069-8400-01 Pfizer 20 ml — — FDA listed —
Octagam Immune Globulin (Human) 50 mg/mL 00069-8451-01 Pfizer 100 ml — — FDA listed —
Octagam Immune Globulin (Human) 50 mg/mL 00069-8476-01 Pfizer 200 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

🏛️
2004
First FDA approval
May 2004
📍
2026
Currently FDA-listed
22 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.

🧪 Avoiding an ingredient? See Human Immunoglobulin G inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

LabelerOctapharma USA Inc
FDA applicationBLA125062 (BLA)
Labeler code68982
First marketedMay 2004
Product typePlasma Derivative
Portfolio24 products on file

More NDCs from Octapharma USA Inc labeler code 68982

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 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.
200 ml68982-0840-04 842 Rx · $2,384,225
100 ml68982-0840-03 85 Rx · $42,331
20 ml68982-0840-01 37 Rx · $12,605
50 ml68982-0840-02 No Medicaid data
500 ml this page68982-0840-05 No Medicaid data
Drug total (last 4 qtrs): 964 Rx · 538,770 units · $2,439,160 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 ✓ Available
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 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 Octapharma USA 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 4 other package presentations of this same product, including 20 ml (68982-0840-01), 50 ml (68982-0840-02), 100 ml (68982-0840-03). 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?
Octapharma USA 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1568 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 68982-0822-01 · Octapharma 68982-0850-01 · Octapharma →
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.