Phenylephrine Hydrochloride · PHENYLEPHRINE HYDROCHLORIDE .1 mg/mL · Solution · Intravenous · Somerset Therapeutics, LLC
NDC 70069-0591-10 · 10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE · ANDA · View full market →
Just 3 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Somerset Therapeutics Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.
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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 →No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Not scored — fragility is computed for NADAC-priced NDCs.
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 in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
No FDA shortage reports for this drug or its presentations.
No enforcement reports list this package NDC.
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Kenvue Brands LLC | PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Leading Pharma, LLC | PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Leading Pharma, LLC | PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Somerset Therapeutics, LLC | PHENYLEPHRINE HYDROCHLORIDE .1 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
DrugDashboards, "Phenylephrine Hydrochloride — NDC 70069-0591-10," retrieved September 3, 2026, https://drugdashboards.com/drug/70069059110.
Free to cite with attribution — see how the data is put together.