Mitigo is a brand name of Morphine sulfate, a prescription medicine. The FDA NDC Directory lists 2 Mitigo products in 2 strengths and forms.

Piramal Critical holds the FDA application for Mitigo (ANDA204393, approved July 16, 2018).

Is there a generic or store brand of Mitigo?

Other products of Morphine sulfate are listed with the FDA, but none in exactly the same strength and form as a Mitigo product.

Mitigo (Morphine sulfate): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Mitigo?: Mitigo is a brand name of Morphine sulfate, a prescription medicine. The FDA NDC Directory lists 2 Mitigo products in 2 strengths and forms.
Who makes Mitigo?: Piramal Critical holds the FDA application for Mitigo (ANDA204393, approved July 16, 2018).
Is there a generic or store brand of Mitigo?: Other products of Morphine sulfate are listed with the FDA, but none in exactly the same strength and form as a Mitigo product.
Has Mitigo been recalled?: No recall linked to Mitigo products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Mitigo is

Each Mitigo 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.

Morphine sulfate · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
morphine sulfate 200 mg/20 mL injection (epidural, intrathecal)	Mitigo	None listed	DailyMed
morphine sulfate 500 mg/20 mL injection (epidural, intrathecal)	Mitigo	None listed	DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Morphine sulfate →

FDA approval

ANDA: Abbreviated New Drug Application: how a generic version is approved.

FDA applications of Mitigo products (Drugs@FDA)
Application	Holder	First approved	Products
ANDA204393	Piramal Critical	July 16, 2018	2

Companies that list Mitigo

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Mitigo products.

Piramal Critical Care, Inc.2 products

Recalls

No recall linked to Mitigo products (by their NDC code or label) appears in the FDA enforcement reports.

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.

Report an error → · Information for medicine makers

Mitigo