Quick answers
- What is Pitocin?
- Pitocin is a brand name of Oxytocin, a prescription medicine. The FDA NDC Directory lists 2 Pitocin products in 1 strength and form.
- Who makes Pitocin?
- PH Health holds the FDA application for Pitocin (NDA018261, approved November 19, 1980).
- Is there a generic or store brand of Pitocin?
- Other products of Oxytocin are listed with the FDA, but none in exactly the same strength and form as a Pitocin product.
- Has Pitocin been recalled?
- FDA enforcement reports list 1 recall of Pitocin products; the newest started June 5, 2012. A recall usually concerns specific lots, not every product.
What Pitocin is
Each Pitocin product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Oxytocin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| oxytocin 10 units/mL injection (intravenous) | Pitocin | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Oxytocin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018261 | PH Health | November 19, 1980 | 2 |
Companies that list Pitocin
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Pitocin products.
- Par Health USA, LLC2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 5, 2012 · Class III · Terminated · D-1420-2012
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02 — JHP Pharmaceuticals, LLC
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.