Quick answers
- What is Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate) used for?
- The FDA-approved label (Dapagliflozin, Biocon Pharma Inc., August 21, 2026) says: “Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate) have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate)?
- 1 company lists prescription products of Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate) in the FDA NDC Directory, including Biocon Pharma Inc..
What Dapagliflozin (dapagliflozin 2,3-butanediol monohydrate) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. …
— FDA label: Dapagliflozin, Biocon Pharma Inc., effective August 21, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Biocon Pharma Inc.2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA211470Biocon Pharma · April 6, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1488569, 1488574 |
|---|---|
| SPL set ID of the quoted label | 828f1004-3647-9a13-8008-c4b3759ecfd0 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dapagliflozin, Biocon Pharma Inc., effective August 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →