Drugplain

DAPAGLIFLOZIN 5 mg/1

DAPAGLIFLOZIN · TABLET, FILM COATED · Alembic Pharmaceuticals Inc.

1 Recall on Record
Plain English

DAPAGLIFLOZIN is a tablet, film coated containing dapagliflozin at 5 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Inc..

Key Facts

Brand Name
DAPAGLIFLOZIN
Generic Name
DAPAGLIFLOZIN
NDC Code (Product)
62332-392
Manufacturer
Alembic Pharmaceuticals Inc.
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA211560
Drug Class
Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
Marketing Start
04/06/2026

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death3,823 reports
acute kidney injury1,487 reports
off label use1,270 reports
dyspnoea1,269 reports
diarrhoea1,202 reports
nausea1,192 reports
fatigue1,175 reports
dizziness1,111 reports
vomiting1,066 reports
diabetic ketoacidosis987 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions ( 5.1 )]. Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablets are likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga ® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information. Dapagliflozin tablets is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Assess renal function prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating. ( 2.1 ) To improve glycemic control, the recommended starting dosage is 5 mg orally once daily. Dosage can be increased to 10 mg orally once daily for additional glycemic control. ( 2.2 ) To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. The recommended dosage is 10 mg orally once daily. ( 2.3 ) See full prescribing information for dosage recommendations in patients with renal impairment. ( 2.2 , 2.3 ) Withhold dapagliflozin tablets for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. ( 2.4 ) 2.1 Testing Prior to Initiation of Dapagliflozin Tablets Assess renal function prior to initiation of dapagliflozin tablets and then as clinically indicated [see Warnings and Precautions ( 5.2 )] . Assess volume status. In patients with volume depletion, correct this condition before initiating dapagliflozin tablets [see Warnings and Precaut…

Contraindications

4 CONTRAINDICATIONS Dapagliflozin is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in dapagliflozin. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with dapagliflozin [see Adverse Reactions ( 6.1 )] . History of serious hypersensitivity reaction to dapagliflozin or any of the excipients in dapagliflozin. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 4: Clinically Relevant Interactions with Dapagliflozin Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when dapagliflozin is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see Warnings and Precautions ( 5.4 )] . Intervention Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during dapagliflozin initiation and dosage changes. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Intervention Monitoring glycemic…

Adverse Reactions

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions ( 5.1 )] Volume Depletion [see Warnings and Precautions ( 5.2 )] Urosepsis and Pyelonephritis [see Warnings and Precautions ( 5.3 )] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions ( 5.4 )] Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see Warnings and Precautions ( 5.5 )] Genital Mycotic Infections [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clin…

Frequently Asked Questions

What is DAPAGLIFLOZIN used for?

DAPAGLIFLOZIN contains DAPAGLIFLOZIN. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is DAPAGLIFLOZIN a controlled substance?

DAPAGLIFLOZIN is not classified as a controlled substance by the DEA.

What is the generic name for DAPAGLIFLOZIN?

The generic name for DAPAGLIFLOZIN is DAPAGLIFLOZIN. There are 11 other brand versions of DAPAGLIFLOZIN.

What is the NDC code for DAPAGLIFLOZIN 5 mg/1?

The NDC (National Drug Code) for DAPAGLIFLOZIN 5 mg/1 is 62332-392, listed by Alembic Pharmaceuticals Inc..

Product NDC

62332-392

Package NDC

62332-392-30

Other DAPAGLIFLOZIN Dosages

Other Dapagliflozin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)