United States · FDA National Drug Code directory
Dapagliflozin and Metformin Hydrochloride
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 33342-408_7d575ca8-9c1f-469d-a341-34daf2f036dd
- Product NDC
- 33342-408
- Form
- TABLET, EXTENDED RELEASE
- Composition / generic term
- Dapagliflozin and Metformin Hydrochloride
- Labeler
- Macleods Pharmaceuticals Limited
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20260406
- Source listing expiry
- 20271231
Source-listed ingredients
- DAPAGLIFLOZIN — 5 mg/1
- METFORMIN HYDROCHLORIDE — 1000 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 3 BLISTER PACK in 1 CARTON (33342-408-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-408-66) · 33342-408-06
- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-07) · 33342-408-07
- 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-09) · 33342-408-09
- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-10) · 33342-408-10
- 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-408-15) · 33342-408-15
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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