NDC 0008-4001
ProtonixI.V. 40 mg per 10 mL injection, powder, for solution
On the label: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Takeda GmbH | Singen (Hohentwiel), Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyNov 12, 2025 · 7 inspections |
| Pharmacia & Upjohn Company LLC | Kalamazoo, MI, United States | Labels it | Problems found, fixed voluntarilyJun 16, 2023 · 9 inspections |
Recalls
- Nov 22, 2016 · Class III · Pfizer Inc.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Lots: Lot #: A) a) 325449, Exp 12/16; b) N97969, N69175, N69177, Exp 03/17; N95727, Exp 04/17; B) M51076, Exp 11/16; and C) a) 317364, Exp 11/16; b) N73763, Exp 03/17
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pantoprazole: every company that makes it
- Form
- injection, powder, for solution, intravenous
- Strength
- 40 mg per 10 mL
- Approval
- NDA NDA020988
- On the market since
- May 1, 2013
- Package NDCs
0008-4001-010008-4001-100008-4001-25- Official label
- DailyMed (National Library of Medicine), updated Dec 22, 2025
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