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Caffeine Citrate

Caffeine Citrate · CAFFEINE CITRATE 20 mg/mL · Injection · Intravenous · Sun Pharmaceutical Industries, Inc.

NDC 47335-0289-27 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 3 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Sun Pharmaceutical Industries Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA090077
TE code
Approval date
Sep 30, 2009
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 Caffeine Citrate (Injection)

LabelerStrengthFirst seenLast seen
Armas Pharmaceuticals Inc.CAFFEINE CITRATE 60 mg/3mLJul 15, 2026Sep 2, 2026
Exela Pharma Sciences, LLCCAFFEINE CITRATE 20 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.CAFFEINE CITRATE 20 mg/mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.CAFFEINE CITRATE 20 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Caffeine Citrate — NDC 47335-0289-27," retrieved September 3, 2026, https://drugdashboards.com/drug/47335028927.

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