Home › NDC Lookup › Drug shortages › Promethazine Hydrochloride Injection

Promethazine Hydrochloride Injection shortage

Promethazine Hydrochloride Injection is currently listed in shortage by the FDA. The FDA lists 10 affected products. The reported reason: Demand increase for the drug; Other. This page was last refreshed from FDA data on Oct 2, 2026.

Current ⚠ Supply risk: Medium Analgesia/Addiction, Gastroenterology, P... 10 products 2 manufacturers 1,047 days · 2.9 yr First posted Nov 21, 2023 Updated Sep 22, 2026
Here’s the bottom line

Promethazine hydrochloride injection has been in shortage for over a year due to high demand. Both the 25 mg/mL and 50 mg/mL strengths still have available supply listed, though amounts are limited and more stock from Hikma is expected around October 2026.

Don’t stop or change your therapy on your own — ask your pharmacist about other manufacturers (see options) and your prescriber about a long-term plan.

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
10
Affected NDCs
2
Reporting manufacturers
2/2
Reporting mfrs supplying
2/2
Affected strengths supplied
56%
NDCs unavailable
1,047
Days in shortage
35,015
Medicaid Rx (2026)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Oct 2, 2026 · yesterday

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Promethazine Hydrochloride Injection. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
10 NDCs
Available 3 Limited 1 Unavailable 5 Other 1
Affected strengths still supplied
Among manufacturers reporting this shortage
2/2 strengths
Sourceable 2
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
2/2 makers
With supply 2
✓ Other manufacturers not reporting a shortage
Still-marketed Promethazine Hydrochloride Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Hikma Pharmaceuticals USA Inc.
Plus 19 alternative dosage forms of Promethazine Hydrochloride.
See all other options & details →
Shortage timeline
  1. Sep 22, 2026
    Currently in shortage
    10 of 10 products affected.
  2. Sep 18, 2026
    FDA refreshed this shortage record
    8 products updated.
  3. Nov 21, 2023
    First reported to the FDA
    10 products first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Hikma Pharmaceuticals USA, Inc. 📞 800-631-2174 8 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35) NDC 00641-1496-35 — Available Additional lots are scheduled to be manufactured. Product will be made available as it is released. —
Current Phenergan, Injection, 50 mg/1 mL (NDC 0641-6083-25) NDC 00641-6083-25 — Unavailable Additional lots are scheduled to be manufactured. Product will be made available as it is released. —
Current Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25) NDC 00641-0929-25 — Limited Availability Estimated recovery: TBD Demand increase for the drug
Current Phenergan, Injection, 50 mg/1 mL (NDC 0641-6085-25) NDC 00641-6085-25 — Unavailable Estimated recovery: TBD Other
Current Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-1495-35) NDC 00641-1495-35 — Available Limited availability Demand increase for the drug
Current Phenergan, Injection, 25 mg/1 mL (NDC 0641-6082-25) NDC 00641-6082-25 — Unavailable Additional lots are scheduled to be manufactured. Product will be made available as it is released. Other
Current Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-0928-25) NDC 00641-0928-25 — Unavailable Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released. Demand increase for the drug
Current Phenergan, Injection, 25 mg/1 mL (NDC 0641-6084-25) NDC 00641-6084-25 — Unavailable Estimated recovery: TBD Other
Manufacturer: XGen Pharmaceuticals DJB, Inc. 📞 866-390-4411 2 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
Current Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 39822-5525-3) NDC 39822-5525-03 — Available — —
Current Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 39822-5550-6) NDC 39822-5550-06 — Unvailable Estimated recovery: TBD Demand increase for the drug

These rows are manufacturer reports to the FDA for Promethazine Hydrochloride Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Promethazine Hydrochloride Injection? options further down this page.

Why is Promethazine Hydrochloride Injection in shortage?

Promethazine hydrochloride injection is on the shortage list primarily because more people need it right now than manufacturers can keep up with — what the FDA calls a "demand increase." This is affecting products from two manufacturers, Hikma Pharmaceuticals USA and XGen Pharmaceuticals.

Here's a quick look at where things stand with Hikma's supply:

  • 25 mg/1 mL (NDC 0641-0928-25): Currently unavailable; Hikma says additional lots should be ready around October 2026.
  • 25 mg/1 mL (NDC 0641-1495-35): Technically available, but only in limited supply.
  • 50 mg/1 mL (NDC 0641-0929-25): Limited availability, with no firm recovery date yet.
  • 50 mg/1 mL (NDC 0641-1496-35): Available, with more lots scheduled to be manufactured and released as they're ready.
  • Several Phenergan-branded 25 mg and 50 mg vials are currently unavailable, with no firm recovery date given for some, and additional lots being scheduled for others.

For XGen, their 50 mg/1 mL is unavailable with no firm recovery date, while their 25 mg/1 mL is currently available. It's worth noting that for some of the unavailable products, the manufacturer listed "Other" as a contributing reason alongside demand, but didn't share any additional specifics publicly.

FDA reason code(s): Demand increase for the drug; Other

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Promethazine Hydrochloride Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Promethazine Hydrochloride Injection?

Promethazine hydrochloride injection is currently on the FDA shortage list. If you or someone you care for uses this medicine, both strengths still have a supply source, so it should be possible to find.

Here is how the strengths look right now. The 25 mg/1 mL and 50 mg/1 mL strengths both still have an available source — no strength is completely without supply at this time. Some specific product lots are marked unavailable or limited, which is why your pharmacy may have to look for a particular version, but the medicine itself is being supplied by both makers on this record.

The reported reason is an increase in demand, along with "other" factors. This shortage has lasted over a year, and some lots are listed with recovery dates that are still to be determined, while additional 25 mg/1 mL lots are expected around October 2026.

Here is what I suggest:

  • Do not stop, skip, or change any dose on your own.
  • Ask your pharmacy to order your strength; they can check wholesalers and both manufacturers for available lots.
  • The same medicine is also made by Hikma in both strengths, so your pharmacy may be able to source one of those, though it may not be in local stock.
  • If your exact product cannot be found, ask your prescriber or pharmacist about options.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls. This is national data and may not match local stock.

See “Where else can I get Promethazine Hydrochloride Injection?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Keep reading
Our full Promethazine guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Promethazine guide →

Where else can I get Promethazine Hydrochloride Injection?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Promethazine Hydrochloride Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE 25 mg/mL Injection · Intramuscular, Intravenous Hikma Pharmaceuticals USA Inc. 00641-0948-35
Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE 50 mg/mL Injection · Intramuscular Hikma Pharmaceuticals USA Inc. 00641-0949-35

Alternative dosage forms of Promethazine Hydrochloride

A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:

Therapeutic equivalents & pricing 10 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Promethazine Hydrochloride 50 mg/mLNDC 00641-0949-35 Hikma 25 ampules $2.339 AP Discontinued
Promethazine Hydrochloride 50 mg/mLNDC 00641-1496-35 Hikma 25 ampules $2.339 AP Discontinued
Promethazine Hydrochloride 50 mg/mLNDC 39822-5550-06 XGen 25 ampules $2.339 AP Availability likely
Promethazine Hydrochloride 50 mg/mLNDC 00404-9942-01 Henry 1 ampule — AP FDA listed
Promethazine Hydrochloride 50 mg/mLNDC 00641-0929-25 Hikma 25 vials — AP FDA listed
Promethazine Hydrochloride 50 mg/mLNDC 00641-0956-25 Hikma 25 vials — AP FDA listed
Phenergan 50 mg/mLNDC 00641-6083-25 Hikma 25 ampules — AP Discontinued
Phenergan 50 mg/mLNDC 00641-6085-25 Hikma 25 vials — AP FDA listed
Promethazine Hydrochloride 50 mg/mLNDC 50090-0879-00 A-S 25 vials — AP FDA listed
Promethazine Hci 50 mg/mLNDC 51662-1248-01 HF 1 ml — AP FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Promethazine Hydrochloride Injection — that fall in the same broad treatment class (antihistamines - 1st generation) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 003867
GCN 14971
HICL code 012014
Ingredient (HICL) Promethazine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.12.00
AHFS class Phenothiazine Derivatives
FDB label name PROMETHAZINE 50 MG/ML AMPUL
FDB brand name Promethazine Hcl
Legend status F — Federal legend — prescription drug or device
GPI-1441400020102010
GPI classPromethazine HCl
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Promethazine Hydrochloride Injection shortage FAQs

Is Promethazine Hydrochloride Injection in shortage?
Yes — the FDA currently lists Promethazine Hydrochloride Injection in shortage (status: “Current”, first reported Nov 21, 2023). 10 of 10 products are affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Why is Promethazine Hydrochloride Injection in shortage?
The manufacturer-reported reason on file with the FDA: Demand increase for the drug; Other. Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released.
Which products are affected?
Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35) (NDC 00641-1496-35); Phenergan, Injection, 50 mg/1 mL (NDC 0641-6083-25) (NDC 00641-6083-25); Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25) (NDC 00641-0929-25). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Promethazine Hydrochloride Injection be available again?
The manufacturer reports: Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released. The FDA does not publish a single guaranteed restock date — confirm with your pharmacy.
Can I still get Promethazine Hydrochloride somewhere?
Other manufacturers (Hikma Pharmaceuticals USA Inc.) still market it and have not reported a shortage. 19 alternative dosage forms of Promethazine Hydrochloride are also listed. See “Where else can I get Promethazine Hydrochloride Injection?” above — stock still varies by pharmacy.
What should I do if I take Promethazine Hydrochloride Injection?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

Still have a question about the Promethazine Hydrochloride Injection shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
← Back to all current drug shortages