DrugDashboards

Gamunex-C

Immune Globulin (Human) · HUMAN IMMUNOGLOBULIN G 10 g/100mL · Injection · Intravenous; Subcutaneous · Grifols Usa, Llc

NDC 13533-0800-24 · 1 VIAL, GLASS in 1 CARTON / 200 mL in 1 VIAL, GLASS · BLA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$9.65per MLinvoice-surveyed acquisition cost · Feb 19, 2025
  • Medicare Part B pays (ASP+6%)$49.01per billing unit (500 MG)HCPCS J1561 · Jul 1, 2026
  • Part D plans paid (avg)$13.01per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$1,239.41per package of 200MLGrifols USA, LLC · Jan 1, 2026

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 13533-0800-12) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$14.89per unit
middle half $14.45$15.57 · 5,181 plans · Apr 1, 2026
Est. net of rebates
$8.93–$11.17
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
94%of plans cover it
tier 5 · prior auth 98% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

$0$5.00$10.00Feb 2025Feb 2025$9.65
1 price point · per ML · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$3,064.00
Reported to Texas DSHS · 2026 annual filing · Grifols USA, LLC

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 500 MG
$49.014
HCPCS J1561 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$37.0M
8,337 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 2 active manufacturers+20
  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

Is this a "specialty" drug?

There's no legal definition — it meets 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $8,176.08 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA125046
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Immune Globulin (Human) (Injection)

LabelerStrengthFirst seenLast seen
Grifols Usa, LlcHUMAN IMMUNOGLOBULIN G 10 g/100mLJul 15, 2026Sep 2, 2026
Kedrion Biopharma, Inc.HUMAN IMMUNOGLOBULIN G 10 g/100mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Gamunex-C — NDC 13533-0800-24," retrieved September 3, 2026, https://drugdashboards.com/drug/13533080024.

Free to cite with attribution — see how the data is put together.