Quick answers
- What is Phenergan?
- Phenergan is a brand name of Promethazine hydrochloride, a prescription medicine. The FDA NDC Directory lists 5 Phenergan products in 3 strengths and forms.
- Who makes Phenergan?
- Hikma holds the FDA application for Phenergan (ANDA083312, approved September 19, 1973). 1 other company (repackagers or distributors) also list Phenergan products.
- Is there a generic or store brand of Phenergan?
- Yes. The FDA NDC Directory lists 34 other products with the same active ingredients, strength and form as a Phenergan product, 34 of them generic. Ask your pharmacist whether one is right for you.
- Has Phenergan been recalled?
- No recall linked to Phenergan products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Phenergan is
Each Phenergan 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.
Promethazine hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| promethazine hydrochloride 12.5 mg tablet (oral) | Phenergan | 15 products, 13 companies | DailyMed |
| promethazine hydrochloride 25 mg/mL injection (intramuscular, intravenous) | Phenergan | 12 products, 6 companies | DailyMed |
| promethazine hydrochloride 50 mg/mL injection (intramuscular) | Phenergan | 7 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Promethazine hydrochloride →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA083312 | Hikma | September 19, 1973 | 4 |
| ANDA040596 | Zydus Pharms USA | November 18, 2005 | 1 |
Companies that list Phenergan
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Phenergan products.
- Hikma Pharmaceuticals USA Inc.4 products
- Direct_Rx1 product
Recalls
No recall linked to Phenergan 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.