Unit-Dose Repackaging Expiration Date (FDA Policy, Commercial Repackagers)
The latest expiration date for a solid oral drug repackaged into unit-dose containers.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Date of repackaging
- 2026-10-01
- Expiration date on the manufacturer's container
- 2027-10-01
- The unit-dose container meets USP <671> Class A or Class B
- Yes
- Light protection equals or exceeds the original container
- Yes
- Original container unopened, and all of it repackaged in one operation
- Yes
- Repackaging and storage met the conditions on the original labeling
- Yes
- The labeling does not caution against repackaging
- Yes
Result: Expiration date no later than December 31, 2026.
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Date of repackaging (YYYY-MM-DD)
- Expiration date on the manufacturer's container (YYYY-MM-DD or YYYY-MM)
- The unit-dose container meets USP <671> Class A or Class B
- Light protection equals or exceeds the original container (answer Yes if the label does not say to protect from light)
- Original container unopened, and all of it repackaged in one operation
- Repackaging and storage met the conditions on the original labeling
- The labeling does not caution against repackaging
How this is calculated
Citation
FDA. Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry. July 2020. Section III: the shorter of 6 months from repackaging and 25 percent of the time to the original expiration date, when five circumstances are present. Read the source ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.