DrugDashboards

Famotidine

Famotidine · FAMOTIDINE 10 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0739-12 · 25 VIAL, SINGLE-DOSE in 1 TRAY / 2 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. A Class I recall hit this product in the past year (Fresenius Kabi USA, LLC). Put together: worth watching — several of the pressures that precede supply trouble are present at once. Historically, drugs in this position went on to a new shortage within 90 days about 0.6% of the time — roughly 4× the typical drug (0.1%).

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)$0.3267per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$0.0080per billing unit (0.25 MG)HCPCS J1308 · Jul 1, 2026
  • Part D plans paid (avg)$0.1614per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$19.01per package of 25X2MLFresenius Kabi, LLC · May 15, 2025

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$0.2$0.4Apr 2026Sep 2026$0.3267
5 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$22.50
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Medicare Part B (ASP)

Payment limit per 0.25 MG
$0.008
HCPCS J1308 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$237,253
55,263 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30● Elevated risk

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

  • 5 active manufacturers+5
  • Class I/II recall in past 12 months+15
  • 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

90-day shortage risk (model v2)

0.6%chance of a new FDA shortage posting for famotidine (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 4× that.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $7.40 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA075813
TE code
AP
Approval date
Apr 16, 2001
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class I · OngoingNov 6, 2025
    Fresenius Kabi USA, LLC — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
  • Class III · TerminatedJun 17, 2020
    HF Acquisition Co. LLC — TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.

Manufacturers of Famotidine (Injection, Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCFAMOTIDINE 10 mg/mLJul 15, 2026Sep 3, 2026
Sagent PharmaceuticalsFAMOTIDINE 4 mg/mLJul 15, 2026Sep 3, 2026
Sagent PharmaceuticalsFAMOTIDINE 10 mg/mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CorporationFAMOTIDINE 20 mg/50mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstFAMOTIDINE 10 mg/mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCFAMOTIDINE 10 mg/mLJul 15, 2026Sep 2, 2026
Athenex Pharmaceutical Division, LLC.FAMOTIDINE 10 mg/mLJul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Famotidine — NDC 63323-0739-12," retrieved September 3, 2026, https://drugdashboards.com/drug/63323073912.

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