Quick answers
- What is Promethazine hydrochloride used for?
- The FDA-approved label (Phenergan, Direct_Rx, March 5, 2026) says: “Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Promethazine hydrochloride have a boxed warning?
- The label we quote has no boxed warning, but 58 of 95 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Promethazine hydrochloride?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 14, 2026). Ask your pharmacist about alternatives.
- Has Promethazine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started May 8, 2014 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Promethazine hydrochloride?
- 44 companies list prescription products of Promethazine hydrochloride in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., A-S Medication Solutions and Asclemed USA, Inc..
What Promethazine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. …
— FDA label: Phenergan, Direct_Rx, effective March 5, 2026. Read the full label on DailyMed →
The FDA has 95 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
58 of 95 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection · Suppository · Solution · Syrup · Injection, solution |
|---|---|
| Route | Oral · Intramuscular · Intravenous · Rectal |
| Prescription products | 129 in the FDA NDC Directory |
| Brand names | Phenergan, Promethegan |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| promethazine hydrochloride 12.5 mg suppository | Generic | $1.98 per suppository |
| promethazine hydrochloride 12.5 mg tablet | Generic | $0.0542 per tablet |
| promethazine hydrochloride 25 mg suppository | Generic | $1.93 per suppository |
| promethazine hydrochloride 25 mg tablet | Generic | $0.0457 per tablet |
| promethazine hydrochloride 25 mg/mL injection | Generic | $1.38–$1.75 per mL 5 packages, lowest to highest |
| promethazine hydrochloride 25 mg/mL injection, solution | Generic | $1.38 per mL |
| promethazine hydrochloride 50 mg suppository | Generic | $26.69 per suppository |
| promethazine hydrochloride 50 mg tablet | Generic | $0.0854 per tablet |
| promethazine hydrochloride 50 mg/mL injection | Generic | $2.34 per mL |
| promethazine hydrochloride 50 mg/mL injection, solution | Generic | $2.34 per mL |
| promethazine hydrochloride 6.25 mg/5 mL solution | Generic | $0.0413 per mL |
| promethazine hydrochloride 6.25 mg/5 mL syrup | Generic | $0.0413 per mL |
NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.13 products
- A-S Medication Solutions12 products
- Asclemed USA, Inc.8 products
- PD-Rx Pharmaceuticals, Inc.7 products
- Bryant Ranch Prepack6 products
- NuCare Pharmaceuticals, Inc.6 products
- Northwind Health Company, LLC5 products
- Proficient Rx LP4 products
- Amneal Pharmaceuticals LLC3 products
- Zydus Lifesciences Limited3 products
- KVK-Tech, Inc.3 products
- BluePoint Laboratories3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Remedyrepack Inc.3 products
- Henry Schein, Inc.3 products
- Amneal Pharmaceuticals of New York LLC3 products
- Cosette Pharmaceuticals, Inc.3 products
- Sportpharm LLC3 products
- Atlantic Biologicals Corp.2 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Coupler LLC2 products
- Actavis Pharma, Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Direct_Rx2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Medical Purchasing Solutions, LLC2 products
- ProPharma Distribution2 products
- XGen Pharmaceuticals DJB, Inc.2 products
- American Health Packaging2 products
- Cardinal Health 107, LLC2 products
- Unit Dose Solutions, Inc.1 product
- Cranbury Pharmaceuticals, LLC1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Major Pharmaceuticals1 product
- Kesin Pharma Corporation1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- PharmPak, Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
- Redpharm Drug1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Quagen Pharmaceuticals LLC1 product
- Xttrium Laboratories, Inc.1 product
- Chartwell RX, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (17)
- ANDA083312Hikma · September 19, 1973
- ANDA083426Watson Labs · September 19, 1973
- ANDA083711Watson Labs · September 21, 1973
- ANDA087953Pharmobedient · November 15, 1982
- ANDA087165Cosette Pharms Nc · August 14, 1987
- ANDA040026Chartwell Rx · September 25, 1998
- ANDA040428Cosette Pharms Nc · February 5, 2002
- ANDA040500Padagis Israel · June 30, 2003
- ANDA040596Zydus Pharms USA · November 18, 2005
- ANDA040643Pharm Assoc · April 26, 2006
- ANDA040712Kvk Tech · July 31, 2006
- ANDA040737Xgen Pharms · April 24, 2008
- ANDA040891Strides Pharma · March 13, 2009
- ANDA091179Amneal Pharms Ny · December 13, 2010
- ANDA091675Cosette Pharms Nc · June 28, 2012
- ANDA213890Quagen · July 12, 2021
- ANDA216446Annora Pharma · November 2, 2022
Shortage status
Current shortage · updated October 14, 2026 · first posted November 21, 2023
| Product | Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25) |
|---|---|
| Availability | Unavailable |
| Reason given | Demand increase for the drug |
| Company | Hikma Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 8, 2014 · Class II · Terminated · D-1342-2014
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01 — Zydus Pharmaceuticals USA Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Phenergan, Direct_Rx, effective March 5, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →