Quick answers
- What is Nalbuphine Hci?
- Nalbuphine Hci is a brand name of Nalbuphine hydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Nalbuphine Hci products in 2 strengths and forms.
- Who makes Nalbuphine Hci?
- Hospira holds the FDA application for Nalbuphine Hci (ANDA070915, approved February 3, 1989).
- Is there a generic or store brand of Nalbuphine Hci?
- Yes. The FDA NDC Directory lists 8 other products with the same active ingredients, strength and form as a Nalbuphine Hci product, 8 of them generic. Ask your pharmacist whether one is right for you.
- Has Nalbuphine Hci been recalled?
- No recall linked to Nalbuphine Hci products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Nalbuphine Hci is
Each Nalbuphine Hci 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.
Nalbuphine hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| nalbuphine hydrochloride 10 mg/mL injection, solution (intramuscular, intravenous, subcutaneous) | Nalbuphine Hci | 5 products, 4 companies | DailyMed |
| nalbuphine hydrochloride 20 mg/mL injection, solution (intramuscular, intravenous, subcutaneous) | Nalbuphine Hci | 3 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Nalbuphine hydrochloride →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA070915 | Hospira | February 3, 1989 | 1 |
| ANDA070918 | Hospira | February 3, 1989 | 1 |
Companies that list Nalbuphine Hci
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nalbuphine Hci products.
- HF Acquisition Co LLC, DBA HealthFirst2 products
Recalls
No recall linked to Nalbuphine Hci 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.