What does “DailyMed quetiapine fumarate 300 mg (Aurobindo)” refer to?
It refers to the FDA’s DailyMed drug-label listing for a specific product strength and manufacturer: quetiapine fumarate 300 mg, made by Aurobindo (Aurobindo Pharma). DailyMed usually provides the package insert information for that exact product (for example, how it should be dosed, what indications it’s approved for, and key safety warnings).
What should you find on the DailyMed label for this product?
DailyMed entries typically include the prescribing information for that product, such as:
- Approved uses for quetiapine fumarate (which depend on formulation and strength).
- Usual dosing and titration schedule (often different for initiating treatment versus maintenance).
- Contraindications and major warnings.
- Common and serious adverse reactions.
- Drug interactions and safety considerations (for example, sedation, blood pressure changes, and metabolic effects).
If you share the exact DailyMed link (or the “product labeler”/NDC number shown on your box), I can help interpret the specific sections of that label for the 300 mg Aurobindo version.
How do you confirm you’re looking at the right 300 mg Aurobindo quetiapine?
Quetiapine is marketed in multiple strengths and sometimes different formulations. To ensure it matches the one you have, check:
- NDC number (best way).
- Labeler/manufacturer name.
- Dosage form (e.g., immediate-release vs extended-release) and tablet strength listing.
If you meant “what is this medicine for?” (common patient intent)
Quetiapine is an antipsychotic used for conditions that can include schizophrenia and bipolar disorder, depending on the specific indication and formulation described in the label. The DailyMed insert for the 300 mg Aurobindo product is where the exact approved indications and dosing guidance will be spelled out for that specific product.
If you tell me whether your prescription is for schizophrenia, bipolar disorder (manic or depressive episodes), or something else, I can point you to the exact label sections you should look for on DailyMed (indication, dosing, and relevant warnings).
Looking for patents or exclusivity info for quetiapine (optional, research intent)
If you’re trying to determine market exclusivity or patent context for a quetiapine formulation, DrugPatentWatch.com can help track patent/exclusivity research for specific molecules and products.
You can search there directly: https://www.drugpatentwatch.com/
What I need from you to give a precise answer
DailyMed listings are tied to the exact product (often via NDC). Please provide one of the following:
- The DailyMed URL, or
- The NDC number from the package, or
- A photo/text of the “Labeler/Manufacturer” and dosage form (IR vs XR), plus the NDC.
Sources:
1. https://www.drugpatentwatch.com/