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Dapagliflozin and Metformin Hydrochloride

Prescription ANDA TE AB
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Dapagliflozin and Metformin Hydrochloride
Generic name
Dapagliflozin and Metformin Hydrochloride
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Macleods Pharmaceuticals Limited
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
8
Packages
24
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dapagliflozin 10 mg/1 1488569 View
Dapagliflozin 5 mg/1 1488569 View
Metformin Hydrochloride 1000 mg/1 860975 View
Metformin Hydrochloride 500 mg/1 860975 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
32

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Biguanide [EPC] EPC All 47 members
Biguanides [CS] CS All 47 members
Sodium-Glucose Cotransporter 2 Inhibitor [EPC] EPC All 16 members
Sodium-Glucose Transporter 2 Inhibitors [MoA] MoA All 16 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
211559
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 6, 2026
Sponsor
MACLEODS PHARMS
Products on application
4
Submissions recorded
1
Products approved under application 211559.
Product Trade name Form Strength Ingredient Status TE Flags
211559-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE Prescription AB
211559-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE Prescription AB
211559-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE Prescription AB
211559-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 211559.
Type No. Action Status Date Review
Original application 1 Approved April 6, 2026 Standard

Adverse event reports

Source: openFDA FAERS
91,381
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: METFORMIN HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
70748-101-06 70748-101 Lupin Pharmaceuticals, Inc. 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-101-06) April 17, 2026
70748-102-07 70748-102 Lupin Pharmaceuticals, Inc. 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-102-07) April 17, 2026
70748-103-06 70748-103 Lupin Pharmaceuticals, Inc. 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-103-06) April 17, 2026
70748-104-06 70748-104 Lupin Pharmaceuticals, Inc. 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-104-06) April 17, 2026
33342-406-06 33342-406 Macleods Pharmaceuticals Limited 3 BLISTER PACK in 1 CARTON (33342-406-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-406-66) April 6, 2026
33342-406-07 33342-406 Macleods Pharmaceuticals Limited 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-07) April 6, 2026
33342-406-09 33342-406 Macleods Pharmaceuticals Limited 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-09) April 6, 2026
33342-406-10 33342-406 Macleods Pharmaceuticals Limited 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-10) April 6, 2026
33342-406-15 33342-406 Macleods Pharmaceuticals Limited 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-15) April 6, 2026
33342-407-06 33342-407 Macleods Pharmaceuticals Limited 3 BLISTER PACK in 1 CARTON (33342-407-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-407-66) April 6, 2026
33342-407-07 33342-407 Macleods Pharmaceuticals Limited 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-407-07) April 6, 2026
33342-407-09 33342-407 Macleods Pharmaceuticals Limited 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-407-09) April 6, 2026
33342-407-10 33342-407 Macleods Pharmaceuticals Limited 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-407-10) April 6, 2026
33342-407-15 33342-407 Macleods Pharmaceuticals Limited 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-407-15) April 6, 2026
33342-408-06 33342-408 Macleods Pharmaceuticals Limited 3 BLISTER PACK in 1 CARTON (33342-408-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-408-66) April 6, 2026
33342-408-07 33342-408 Macleods Pharmaceuticals Limited 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-07) April 6, 2026
33342-408-09 33342-408 Macleods Pharmaceuticals Limited 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-09) April 6, 2026
33342-408-10 33342-408 Macleods Pharmaceuticals Limited 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-10) April 6, 2026
33342-408-15 33342-408 Macleods Pharmaceuticals Limited 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-15) April 6, 2026
33342-409-06 33342-409 Macleods Pharmaceuticals Limited 3 BLISTER PACK in 1 CARTON (33342-409-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-409-66) April 6, 2026
33342-409-07 33342-409 Macleods Pharmaceuticals Limited 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-409-07) April 6, 2026
33342-409-09 33342-409 Macleods Pharmaceuticals Limited 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-409-09) April 6, 2026
33342-409-10 33342-409 Macleods Pharmaceuticals Limited 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-409-10) April 6, 2026
33342-409-15 33342-409 Macleods Pharmaceuticals Limited 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-409-15) April 6, 2026
70748-101 70748-101 Lupin Pharmaceuticals, Inc. — April 17, 2026
70748-102 70748-102 Lupin Pharmaceuticals, Inc. — April 17, 2026
70748-103 70748-103 Lupin Pharmaceuticals, Inc. — April 17, 2026
70748-104 70748-104 Lupin Pharmaceuticals, Inc. — April 17, 2026
33342-406 33342-406 Macleods Pharmaceuticals Limited — April 6, 2026
33342-407 33342-407 Macleods Pharmaceuticals Limited — April 6, 2026
33342-408 33342-408 Macleods Pharmaceuticals Limited — April 6, 2026
33342-409 33342-409 Macleods Pharmaceuticals Limited — April 6, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.