NDC 68982-0840-01 — Octagam Immune Globulin (Human) 50 mg/mL, 20 mL

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68982-840-01

Product NDC 68982-840

11-digit billing NDC 68982084001

NCPDP billing unit ML — per mL (volume)

Application # BLA125062

SPL Set ID de00abeb-d635-eddc-b603-10708ecef5aa

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 68982-840-01 — 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 → 68982-0840-01. 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 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Immune Globulin — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Immune Globulin (17 interactions) — ranked by severity →

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

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	$7.16	$143.24 / 20 ml
Medicare drug plans payPart D · Q2 2026	$10.51	$210.13 / 20 ml
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.

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

Billing & reimbursement

FDA NDC (as labeled)68982-840-01

11-digit billing NDC68982-0840-01

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 20 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.

CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
DMEPDAC NDC-HCPCS crosswalk
openFDA NSDE billing units · refreshed Oct 7, 2026

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
68982-0840-01 You're viewing this	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 68982-840-05	500 mL in 1 BOTTLE, GLASS	2004-05-21	—	Active

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

This pack accounts for about 3.8% of this product's recent Medicaid fills; most go to the 200 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?

This package contains 20 mL — 20 ml in 1 bottle, glass.

How does this package differ from NDC 68982-0840-02?

Both are Octagam Immune Globulin (Human) 50 mg/mL Solution — the drug itself is identical. This page's package is the 20 mL one, while NDC 68982-0840-02 is the 50 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Octagam Immune Globulin (Human) 50 mg/mLthis 68982-0840-01	Octapharma	20 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.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA Purple Book · refreshed Oct 5, 2026
CMS NADAC weekly file

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.

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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.

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.

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

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

🔎 All NDCs from Octapharma USA 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.

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

📄 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 & 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

37

Units reimbursed last 4 qtrs

1.8K

Gross reimbursed last 4 qtrs

$12.6K

Avg / prescription

$340.67

Avg / unit

$7.1618

Latest quarter Q1 2026

0Rx

Fee-for-service vs managed care ⓘ

38% FFS 62% MCO

Fee-for-service · 14 Rx Managed care · 23 Rx

State Medicaid map

Units reimbursed · per 100k residents

55.155.1

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

🏆 Top states by units · per 100k residents

1 Nevada 55.1 /100k

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.

200 ml68982-0840-04 842 Rx · $2,384,225

100 ml68982-0840-03 85 Rx · $42,331

20 ml this page68982-0840-01 37 Rx · $12,605

50 ml68982-0840-02 No Medicaid data

500 ml68982-0840-05 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	✓ Available
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)	✓ 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 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 50 ml (68982-0840-02), 100 ml (68982-0840-03), 200 ml (68982-0840-04). 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?

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.

Related NDC lookups

🧪 All Immune Globulin NDCsSame ingredient 🏭 All Octapharma labeler NDCsLabeler code 68982 📚 All Human Immunoglobulin G NDCsDrug class 🧾 J1568 billing & NDC crosswalkJ-code

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 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 Cytomegalovirus Immune Globuln 44206-0532-11

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.

First Databank (licensed) · refreshed Oct 8, 2026

Octagam Immune Globulin (Human) 50 mg/mL Solution, 20 mL — NDC 68982-840-01 (Billing 68982-0840-01)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Clinical

Patient education

Supplement & herbal interactions

Pricing

Billing & reimbursement

Packaging — all sizes for this product

Pack size FAQ

Therapeutic equivalents

Availability & biosimilar status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from Octapharma USA Inc labeler code 68982

Full FDA label FDA SPL

Medicaid utilization & spend

Medicaid utilization by pack size

About this NDC listing & data coverage

Questions about this listing