Does carglumic acid expire?
The printed date covers the sealed pack. Once carglumic acid is opened, mixed or diluted, its label sets a second and usually much shorter limit — quoted below, per product.
Shortest limit on any carglumic acid label: 90 days
“Discard bottle after 90 days from first opening.”
That applies to the product it is printed on, not to every form of carglumic acid — check which one you have against the list below.
What the labels say
“Discard bottle after 90 days from first opening.”
On the label for Carglumic Acid · DailyMed
How the label says to keep carglumic acid
Storage is the other half of the question: the stability behind any date assumes these conditions, and a medicine kept outside them ages faster than the calendar says.
- “Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original unopened bottle.”
- “Store at room temperature between 15°C and 30°C (59°F and 86°F).”
- “Keep the bottle tightly closed between openings in order to protect from moisture.”
- “[see How Supplied/Storage and Handling ( 16 )] Store UNOPENED bottle in a refrigerator at 2°C to 8°C (36°F to 46°F).”
- “After first opening of the bottle: do not refrigerate, store at room temperature between 15°C and 30°C (59°F and 86°F).”
- “Keep the bottle tightly closed in order to protect from moisture.”
- “Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].”
- “[see How Supplied/Storage and Handling (16)] Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].”
Frequently asked questions
Does carglumic acid expire?
Two different clocks apply and only one of them is the printed date. The date on a sealed pack is the manufacturer's guarantee for the unopened product. Once it is opened, mixed or diluted, the label imposes its own limit — as tight as 90 days on some carglumic acid products, and that is the number quoted on this page.
Can I still use carglumic acid after the date on the box?
This page cannot tell you that, and nor can any page. The FDA's own shelf-life programme found 88% of tested lots stayed within specification at least a year past expiry — and concluded in the same breath that lot-to-lot variation means this can only be confirmed by testing each lot. What you can check at home is the in-use limit above and whether the product has been stored as the label requires. Ask a pharmacist about a specific pack; they will also dispose of what you no longer need.
Why do different carglumic acid products have different limits?
Because they are different formulations. A suspension that gets mixed with water, a pen that gets carried at room temperature, and a sealed tablet do not behave alike, so each manufacturer's label sets its own limit and each is shown here with the product it belongs to. We never merge them into one number for the molecule.
More on carglumic acid
Quoted from FDA labels for reference, not medical advice, and not a suggestion to use anything past its limit. If you are unsure whether a pack is still good, a pharmacist can tell you and can dispose of it safely.