This NDC is on FDA's drug shortage list (posted Nov 21, 2023)
Reported reason: Demand increase for the drug
Product Information
PROMETHAZINE 25 MG/ML AMPUL is a generic product labeled by Hikma Pharmaceuticals USA Inc., priced at $1.3345 per ML under NDC 00641149535. Its NADAC has been published 367 times since Nov 28, 2013.
FDA first approved this application before 1982. Its Orange Book therapeutic-equivalence code is AP.
Strength
25 mg/mL
Manufacturer
Hikma Pharmaceuticals USA Inc.NDC
00641149535
Classification
Generic
Dosage Form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Effective Date
9/23/2026
Active Ingredients
PROMETHAZINE HYDROCHLORIDEApproval Type
Generic (ANDA)
FDA Application
ANDA083312FDA Approved
Before 1982
TE Code
AP
On Market Since
9/19/1973
Pharmacological Classes
Price Statistics
The NADAC for PROMETHAZINE 25 MG/ML AMPUL has been published 367 times since Nov 28, 2013, and over the history we have for it it has risen 24.1%. The table below summarizes its recorded NADAC range and movement.
| Current price | $1.3345 per ML |
|---|---|
| All-time high | $1.7806 (Sep 14, 2022) |
| All-time low | $0.9845 (Aug 20, 2014) |
| 52-week high | $1.6534 |
| 52-week low | $1.2697 |
| Median price | $1.5593 |
| Average price | $1.4897 |
| Largest weekly change | +72.5% (Dec 17, 2014) |
| Weeks tracked | 367 |
| Tracking since | Nov 28, 2013 |
Generic Alternatives
The matcher finds 1 manufacturer offering a NADAC-published product with this drug's active ingredient and strength in a comparable dosage form (cheapest from each manufacturer, up to 10 shown below). None of the shown alternatives sit below the current price. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.
Related Drugs
Same classification
Continue researching this drug
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Manufacturer
Hikma Pharmaceuticals USA Inc. manufacturer profile
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Drug market
Promethazine Hydrochloride market comparison
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Therapeutic class
Phenothiazine class view
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Trend hub
Latest market trends
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Guide
Understanding NADAC pricing
Use the explainer when you need context on how CMS publishes NADAC and how to interpret the number on this page.
Frequently asked questions
What is the NADAC price of PROMETHAZINE 25 MG/ML AMPUL?
The current National Average Drug Acquisition Cost (NADAC) for PROMETHAZINE 25 MG/ML AMPUL, manufactured by Hikma Pharmaceuticals USA Inc., is $1.3345 per ML (NDC 00641149535), effective Sep 30, 2026.
How has the price of PROMETHAZINE 25 MG/ML AMPUL changed over time?
Over the history we have for it, the NADAC for PROMETHAZINE 25 MG/ML AMPUL has risen 24.1%. It has been tracked across 367 weekly CMS publications since Nov 28, 2013.
What are the highest and lowest recorded NADAC prices for PROMETHAZINE 25 MG/ML AMPUL?
Since Nov 28, 2013, the NADAC for PROMETHAZINE 25 MG/ML AMPUL has ranged from a low of $0.9845 (Aug 20, 2014) to a high of $1.7806 (Sep 14, 2022), with a median of $1.5593 per ML.
Are there cheaper alternatives to PROMETHAZINE 25 MG/ML AMPUL?
1 manufacturer publishes a NADAC-priced product with the same active ingredient and strength as PROMETHAZINE 25 MG/ML AMPUL in a comparable dosage form, but none are currently priced below it.
Who manufactures PROMETHAZINE 25 MG/ML AMPUL?
PROMETHAZINE 25 MG/ML AMPUL (NDC 00641149535) is labeled by Hikma Pharmaceuticals USA Inc., and CMS classifies it as a generic product.
Is PROMETHAZINE 25 MG/ML AMPUL in shortage?
Yes — NDC 00641149535 is currently listed in FDA's drug shortage database (posted Nov 21, 2023). Reported reason: Demand increase for the drug.